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ST
J.S.S COLLEGE OF NURSING
MAIN SARASWATHIPURAM, MYSORE
SYNOPSIS SUBMISSION
BY,
Ms. TINU CHITTILAPPILLY
1ST YEAR M.Sc NURSING
J.S.S COLLEGE OF NURSING
1ST MAIN, SARASWATHIPURAM
MYSORE- 570009
GUIDE:
Dr. BHARTI.M.
PROFESSOR AND PRINCIPAL
J.S.S COLLEGE OF NURSING
1ST MAIN, SARASWATHIPURAM,
MYSORE- 570009
BATCH: 2009-2011
PERFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1
NAME OF THE CANDIDATE
Ms . TINU CHITTILAPPILLY
AND ADDRESS
1ST YEAR MSc NURSING
(IN BLOCK LETTERS)
J.S.S COLLEGE OF NURSING
MYSORE
2
NAME OF THE INSTITUTE
J.S.S COLLEGE OF NURSING
MYSORE
3
4
COURSE OF THE STUDY
1ST YEAR MSc NURSING
AND SUBJECT
MEDICAL- SURGICAL NURSING
DATE OF ADMISSION OF THE 27.06.2009
COURSE
5
TITLE OF THE TOPIC
A STUDY TO DETERMINE THE EFFECTIVENESS
OF ORAL ICE CUBES VERSUS SALINE MOUTH
WASH ON THE
PREVENTION
OF ORAL
MUCOSITIS AMONG PATIENTS RECEIVING
CHEMOTHERAPY IN SELECTED HOSPITALS OF
KARNATAKA.
6. BRIEF RESUME OF THE INTENDED WORK
6.0 INTRODUCTION
Cancer is one of the second largest killer diseases next to the heart disease. The
worldwide incidence of cancer is estimated at seven million with an annual mortality of
about five millions1 .The three leading causes of death due to cancer are cancer of lung
17.8%, stomach 10.4% and liver 8.8%2 .
Management of cancer consists of surgery, radiation and chemotherapy. Among these
chemotherapy is the commonest treatment modality which controls the uncontrolled
cell division by interfering with cellular function and reproduction. Chemotherapy may
be used to reduce tumor size preoperatively, to destroy any remaining tumor cells
postoperatively, or to treat some forms of leukaemia. Cells with rapid growth rates eg
bone marrow, epithelium, hair follicles, sperm are very susceptible to damage due to
chemotherapy. The rapid rate of proliferation of epithelial lining of oral cavity makes it
susceptible to the effect of chemotherapy resulting in oral mucositis3.
The exact pathophysiology of mucositis is not fully elucidated, but it is thought to have
two mechanisms: direct mucositis and indirect mucositis, caused by chemotherapy
and/or radiation therapy.
Direct Mucositis - The epithelial cells of the oral mucosa undergo rapid turnover,
usually every 7 to 14 days, which makes these cells susceptible to the effects of
cytotoxic therapy. Both chemotherapy and radiation therapy can interfere with the
maturity and cellular growth of epithelial cells, causing changes to normal turnover and
cell death.
Indirect Mucositis - Oral mucositis can also be caused by the indirect invasion of gramnegative bacteria and fungal species. Patients are at increased risk for oral infections
when they are neutropenic, and this usually happens when indirect stomatotoxicity
appears. The onset of mucositis secondary to myelosuppression varies, depending upon
the timing of the neutrophil count associated with the chemotherapy agent
administered, but typically develops anywhere from 10 to 21 days after chemotherapy
administration4 .
6.1 NEED FOR THE STUDY
Prevalence rate of oral mucositis in cancer patients have been estimated upto 40% in
patients receiving standard dose chemotherapy, 90% in head and neck cancer patients
subjected to chemo– radiotherapy and 99% in patients undergoing high dose
myeloablative chemotherapy for hematopoietic stem cell transplant. Oral mucositis is a
complex process of biologic phenomena primarily related to the type and dosage of
cancer therapy. Clinically, oral mucositis is usually observed three to five days after
initiation of chemotherapy. Chemotherapy induced oral mucositis reaches peak
intensity at 7 -14 days and slowly resolves unless complicated by infection or repeated
drug administration5.
Mucositis is described as an inflammatory and ulcerative lesion in the oral cavity.The
suffering caused by oral mucositis is multifaceted. High level of oral dysfunction has
been reported in cancer patients with oral mucositis which include dysphagia, dry
mouth, changes in food taste etc. Because of pain & difficulty in swallowing associated
with mucositis, nutritional intake can be impaired resulting in dehydration and weight
loss, which may even neccesiate the patient to be hospitalized for fluid support.
Mucositis may be further complicated by infection or bleeding and it becomes difficult
for patients to maintain their oral hygiene & decreases their quality of life5.
Mucositis is one of the most common adverse reactions encountered in radiation
therapy for head and neck cancers, as well as in chemotherapy, in particular with drugs
affecting DNA synthesis (S-phase-specific agents such as fluorouracil, methotrexate,
and cytarabine). Mucositis may limit the patient's ability to tolerate chemotherapy or
radiation therapy, as the nutritional status is compromised. It may drastically affect
cancer treatment as well as the patient's quality of life. The incidence and severity of
mucositis will vary from patient to patient. It will also vary from treatment to
treatment6.
Many treatment options are available to prevent and treat this condition, but none of
them can completely prevent or treat mucositis. More and more pathological methods
are being developed to understand this condition so that better therapeutic regimens can
be selected. Emphasis also should be made in assessing the patient's psychologic
condition, in particular depressive disorders. This is important because treatment with
antidepressants will not only contribute in lifting depression but also reduces pain
somatization. Although mucositis is rarely life-threatening, it will interfere with
treatment of cancer to a great extent4.
Symptoms of mucositis vary from pain and discomfort to an inability to tolerate food or
fluids. Mucositis may also limit the patient's ability to tolerate either chemotherapy or
radiation therapy, resulting in dose-limiting toxicity and hence drastically affecting
cancer treatment and outcome. It is estimated that there is an increased risk of mucositis
development with bolus and continuous infusions compared to prolonged or repetitive
administration of lower doses of cytotoxic agents6.
At present there is no standard precaution to prevent or treat mucositis developed as a
side effect of cancer management. Preventive measures directed towards aetiology of
oral mucositis are gaining importance. Preventing a complication beforehand is easier
& less costly than treating it. In this context, oral cooling (cryotherapy- using oral ice
chips) has become a cheap & readily applicable method in preventing or decreasing
oral mucositis, developing due to rapid infusion of chemotherapy agents. Cryotherapy
causes local vasoconstriction, which inturn reduces the blood flow in oral mucosa &
reduces the amount of drug distributed to cells, hence reducing the incidence of oral
mucositis7.
Studies have shown that an oral care protocol (tooth brushing, chlorhexidine rinse
[0.2%], and saline) resulted in a 38% reduction in incidence and a significant reduction
in severity and associated oral pain in pediatric patients with cancer8. Ice chips or saline
mouth rinse may lessen the severity or help prevent symptoms of mucositis or mouth
sores in patients receiving melphalan and autologous stem cell transplant for multiple
myeloma. It is not yet known whether ice chips are more effective than saline mouth
rinse in reducing or preventing mucositis9.
Some research studies done abroad have revealed that both ice cubes and saline
mouth wash has some effect in preventing mucositis caused by chemotherapy. As both
the agents have some advantages and disadvantages, the researcher felt interested in
comparing the effect of saline and ice cubes on development of oral mucositis in
patients undergoing chemotherapy inorder to develop practical evidence which is
useful in preventing oral mucositis among patients receiving chemotherapy.
6.2 REVIEW OF THE LITERATURE
INCIDENCE, PATHOGENESIS, AND PREDISPOSING FACTORS FOR ORAL
MUCOSITIS
Approximately 400,000 patients per year may develop acute or chronic oral
complications during chemotherapy. Up to 40% of patients treated with
conventional chemotherapy
and
more
than
70%
of
patients
undergoing
conditioning therapy for bone marrow transplantation experience oral treatment-related
complications. The incidence is also higher in patients who receive continuous infusion
therapy for breast and colon cancer and in those who receive adjuvant therapy for head
and neck tumors. However, in patients of the same age with similar diagnoses and
treatment regimens and equivalent oral health status, the incidence of oral mucositis
may vary considerably. This is most likely because of genetic differences and other
factors that are not yet fully characterized or understood6,10.
The pathophysiology of oral mucositis is based on 5 interrelated phases, including an
initiation phase, a message generation phase, a signaling and amplification phase, an
ulceration phase, and a healing phase. In the initiation phase, the chemotherapeutic
agents lead to the generation of free radicals and DNA damage. In the message
generation phase, transcription factors are activated, which then up-regulate a number
of proinflammatory cytokines such as interleukin(IL-1) and tumor necrosis factor-alpha
(TNF-alpha). These mediates inflammation and dilates vessels, potentially increasing
the concentration of chemotherapeutic agents at the site resulting in erythema from
increased vascularity and epithelial atrophy 4-5 days after the initiation of
chemotherapy. Microtrauma from day-to-day activities, such as speech, swallowing,
and mastication, leads to ulceration. The third phase is ulcerative phase which occurs
due to epithelial breakdown and it usually develops one week after initiation of
chemotherapy.During this phase (during which time neutropenia has developed),
bacterial colonization of ulcerations occurs, resulting in the flow of endotoxins into
mucosal tissues and the subsequent release of more IL-1 and TNF-alpha. This is likely
the phase most responsible for the clinical pain and morbidity associated with oral
mucositis. During the fifth and final healing phase, cell proliferation occurs with
reepithelialization of ulcers. Signals from the extracellular matrix induce epithelial cells
to migrate underneath the pseudomembrane of the ulcer. The epithelium then
proliferates so that the thickness of the mucosa returns to normal. Reconstitution of the
WBCs in neutropenic patients effects local control of bacteria, which also contributes
to resolution of the ulcers. The duration of the healing phase, usually lasting from
day 12 to 16, again critically depends upon epithelial proliferation rate, hematopoietic
recovery, reestablishment of the local microbialflora, and the absence of factors
interfering with wound healing, such as infection and mechanical irritation6,10.
Risk factors such as age, nutritional status, type of malignancy, and oral care during
treatment will play important roles in the development of mucositis. Other factors
which influence an individual’s risk for development of mucositis include defects of
certain metabolic enzymes and DNA repair mechanism, deficiency of folic acid and
vitamin B12 , impaired renal or hepatic function that can delay elimination of antineoplastic agent, pleural or peritoneal effusions, or administration of specific antidotes
such as leucoverin. Underlying hematologic malignancy and preexisting oral pathology,
including xerostomia, also promote mucositis4,6. An increased rate of oral mucositis is
seen in patients with hematologic malignancies, those receiving stomatotoxic agents
which include the antimetabolites 5-fluorouracil, methotrexate, and cytarabine,
concomitant radiation therapy (especially to the head and neck region) increases the
risk of oral mucositis because of synergistic effects with the chemotherapeutic agents.
Chronic irritation from ill-fitting prostheses, hyposalivation prior to and during
treatment, younger age, presence of concomitant oral infections is associated with an
increased risk of oral mucositis.. Better pretreatment oral health is probably associated
with a reduced incidence of and less severe oral mucositis.10
The earliest signs and symptoms of oral mucositis include erythema and edema, a
burning sensation, and an increased sensitivity to hot or spicy food. Erythematous areas
may develop into elevated white desquamative patches and subsequently into painful
ulcers . This affects the fluid and nutritional intake of patients resulting in
malnutrition and dehydration which further interfere with mucosal regeneration. Within
the oral cavity, the soft palate, cheeks and lips, the ventral surface of the tongue, and
the floor of the mouth are most vulnerable to direct stomatotoxicity, whereas the
gingiva, dorsal surface of the tongue, or the hard palate are rarely affected—probably
due to their slower rate of cellular turnover. Both pharmacological and non
pharmacological measures have been adopted to control or manage oral mucositis
associated with chemotherapy. Locally applied non pharmacological measures include
maintenance of oral hygiene and oral cryotherapy6.
A descriptive cross-sectional study was conducted to investigate patient’s self reported
oral dysfunction in relation to oral mucositis and to examine the extent to which oral
dysfunction and distress correlate with oral mucositis. Eighty eight subjects presenting
with WHO grade >2 oral mucositis during 7-14 days after the initiation of
chemotherapy and the last week of head and neck irradiation were enrolled in the study.
Subjects were asked to indicate their intensity and distress of oral mucositis and
associated oral dysfunction using 1-4 and 0-4 point rating scale respectively. Dry
mouth and distorted taste were reported in 72% and 63% subjects separately. 57% and
40% subjects reported weight loss and dysphagia respectively. The intensity of oral
mucositis was significantly correlated with the intensity (r = .4-.6) and the distress
scores (r = .4-.6) of oral dysfunction5.
A prospective, repeated measure descriptive pilot study was conducted with the aim to
describe patterns of oral pain and mucositis in patients receiving bone marrow
transplant or high dose chemotherapy for leukaemia. 18 samples were selected by
purposive sampling who received same prophylactic antimicrobial, antiviral and
antifungal agents and the same oral care regimen. Data were collected at baseline, then
daily through patient interviews, oral examination, and chart review for atleast 3 weeks
or until discharge. Two pain related instruments, Pain Assessment Form (PAF) and the
Verbal Descriptor Scale (VDS) was used for patients to report pain. Mucositis was
measured with the Oral Assessment Guide (OAG) and Oral Mucositis Index (OMI).
Emotional distress was assessed using 11-item Brief Profile of Mood States (BPOMS).
The results showed that there was mild to moderate pain in nearly 70% of patients
which was described as ‘tender’, ‘irritating’ and ‘sore’. Patients used pain medicines,
mouth care, and mental and physical activities to relieve pain, and reported partial
overall relief of pain. Mucositis was mild, with the tongue, buccal mucosa and labial
mucosa most affected. With respect to mood disturbance it was found that patterns of
pain, mucositis, and mood disturbance were consistent with each other11.
PREVENTIVE MEASURES TO CONTROL ORAL MUCOSITIS ASSOCIATED
WITH CHEMOTHERAPY
Prevention and treatment of chemotherapy-and radiotherapy-induced mucositis remain
a major and unsolved problem, which limits the efficacy of cancer treatment and is very
uncomfortable for the patients. Prophylactic oral and dental care remains as the major
requisite to reduce incidence of mucositis. After cancer treatment, oral hygiene,
inhibition of oral flora and pain relief are the main goals. A multidisciplinary approach
and careful evaluation are mandatory, with the emphasis on inhibition of epithelial cell
proliferation during drug exposure and facilitation of epithelial healing and maturation
after chemotherapy12.
Clinical practice guidelines for the prevention and treatment of cancer therapy-induced
oral mucositis included measures like maintenance of oral hygiene by following oral
care protocols which include use of soft toothbrush that is replaced on a regular basis. It
recommended the regular assessment of oral cavity and oral pain using validated
instruments. The use of patient-controlled analgesia with morphine as the treatment of
choice was suggested for oral mucositis pain in patients undergoing hematopoietic stem
cell transplantation. For patients receiving Standard-Dose Chemotherapy, as in case of
those receiving bolus dose of 5-fluorouracil (5-FU) or edatrexate the panel suggested
the use of oral cryotherapy for 30 minutes and 20-30minutes respectively to reduce the
incidence of oral mucositis. For those receiving high-dose chemotherapy with or
without total body irradiation plus hematopoietic stem cell transplantation( HCST) it
was suggested the use of keratinocyte growth factor and use of low-level laser therapy.
In patients receiving high-dose melphalan it was recommended the use of cryotherapy
to prevent oral mucositis13. In a series of 18 patients receiving melphalan only one
developed grade 3 mucositis when ice pops were sucked 5 min before and stopped 5
min after a melphalan infusion before marrow transplantation14.
Traditional measures to control mucositis included good dental hygiene and treating
any dental caries before anti-cancer treatment. Mouth washes composed of glycerine
and thymol and glycerine and lemon which were used traditionally are found to be
ineffective. Sodium bicarbonate mouthwashes was found to be harmful if too
concentrated by altering oral pH and hydrogen peroxide has been shown to be no more
effective than a saline mouthwash. A trial was done in leukemic patients to compare the
effectiveness of chlorhexidene vs chlorhexidine and nystatin.The study revealed that
plain saline to be as effective as the other two agents14.
In another study, the effects of povidone-iodine and normal saline mouthwashes on oral
mucositis was compared in patients after high dose chemotherapy. In the study, 132
patients were randomized to use normal saline (n=65) or povidone-iodine diluted 1:100
(n=67) mouthwashes for oral mucositis prophylaxis and treatment after high-dose
chemotherapy followed by autologous peripheral stem cell transplantation. The study
groups were well balanced in respect of age, sex, chemotherapy and the number of
CD34+ cells in the graft. No significant difference was found between the groups in
respect of oral mucositis characteristics, fever of unknown origin and other infections.
The antimicrobial solution was less tolerable for patients. Oral mucositis occurred
significantly more often in females than in males (86% vs 60%, P=0.0016) and was
worse and of longer duration. The mechanical effect of mouthwashes might have a
certain importance in prevention of fever of unknown origin15. In nutshell it can be
concluded that frequent mechanical cleansing of the mouth by a simple saline solution
is more effective compared to more sophisticated mouthwashes which can be harmful.
Normal saline (.9%) is a not irritant and is believed to help in formation of granulation
tissue and to promote healing. Its safe, economical and readily available mouthwash
the use of which can be promoted16.
Topical agents which include topical anesthetics such as viscous lidocaine are
frequently combined with other agents to make mouthwashes. Other commonly used
ingredients include dyphenhydramine, milk of magnesia, and chlorhexidine. A
randomized clinical trial performed with 142 patients to evaluate the effectiveness of
three different mouthwashes for chemotherapy-induced mucositis, and found evidence
to support only routine oral hygiene, and the use of the inexpensive salt and soda
mouthwash was effective. Other topical agents that may demonstrate a role in pain
management include doxepin, a trycyclic antidepressant, topical morphine sulphate,
topical capsaicin and sucralfate17.
The diet in patients with mucositis must be of high caloric values. In case of patients
with grade I and II mucositis, the patient should avoid intake of spicy and salty food as
well as the food which can damage mucous, such as biscuits, toast, tough meat. The
patient should also avoid intake of alcohol and hot drinks. If patients are unable to take
food in normal way, parentral nutrition may have to be started18.
EFFECT OF ORAL CRYOTHERAPY IN REDUCING ORAL MUCOSITIS
Ice in the mouth
causes local vasoconstriction and may reduce the uptake of 5-
fluorouracil into mucosal cells. As the plasma halflife of this drug is short (5-20 min),
patients were asked to suck icechips for 5 min before and 30 min after injection for 5
days. A total of 95 patients were randomized to suck ice or to serve as a control group
during the first cycle of chemotherapy and subsequently crossed over in the next cycle.
Mucositis was reduced significantly (P = 0.002). Apart from numbness of the mouth
and 'ice cream' headaches, the ice was well tolerated14.
A study was conducted to assess the effectiveness of oral cryotherapy on the
development of chemotherapy induced oral mucositis . The study involved 60 patients,
30 in experimental group & 30 in control group. Ice cubes whose corners have been
smoothened & which can be moved easily in mouth were used in study group .
Cryotherapy was initiated five minutes before chemotherapy & maintained during
infusion of chemotherapeutic agents. According to patient judged mucositis grading,
the rate of mucositis in study group was 36.7% and in control group it was 90%.
According to physician judged mucositis grading , the rate of mucositis in study group
was 10% and in control group it was 50%. Oral PH values decreased in 90% of subjects
in study group (i.e. mucositis risk was reduced) whereas oral PH remained unchanged
in 86.7% in control group7.
Two comparitive studies were conducted to compare plain ice and flavoured ice for
preventing oral mucositis associated with use of 5 flurouracil. In one study 79 patients
were randomized to receive each of 3 interventions across 3 cycles of chemotherapy.
1)Standard care with use of mouthwash and use of soft tooth brush
2) standard care
plus plain ice & 3) standard care plus flavoured ice. Cryotherapy involved swirling ice
chips around mouth for 5 minutes prior to, 5 minutes during & 20 minutes after the
injection. Oral mucositis was assessed by nurses prior to commencing each of the three
chemotherapy cycles & 15 days after each intervention. Data analysis confirmed that
both forms of oral cryotherapy were effective in reducing severity of oral mucositis as
compared to the standard care alone. However side effects like nausea, taste problems
& headache were reported more frequently with flavoured ice19.
In a similar study done involving 22 cancer patients receiving 5- Fluoro-uracil, the
effectiveness of flavoured ice versus plain ice was checked using the visual analogue
scale. The assessment scores of plain ice cubes were different from the score of the
flavoured ice cubes on the 5th day as well as on the 15th day. The assessment on 5th day
shows that 10 (45.5%) patients who received plain ice cubes had mucositis and
remaining 12 (54.5%) did not have mucositis and on 15th day 20 (90.9%) patients had
no mucositis and 2 (9.1%) patients had mucositis. But after sucking the flavoured ice
cubes no patient had mucositis either on 5th day or 15th day and most of the patient’s 20
(99.1%) preferred to have flavoured ice cubes for the next cycle after both the
treatments of plain and flavoured ice cubes2.
A study was conducted to determine the effects of the combined prophylaxis of oral
cooling (cryotherapy) and administration of propantheline, an anticholinergic drug, in
patients (aged 2-16 year) with acute leukemias or solid tumors, who underwent
myeloablative chemo-radiotherapy and autologous peripheral blood stem cell rescue
from 1993 to 1997. Patients were pretreated with the combined prophylaxis (n = 12) or
single prophylaxis (n = 5), or left untreated (n = 7). The combined prophylaxis
significantly reduced the severe mucositis (combined, 8.3%; single, 20.0%; and
untreated, 42.9%) and severe diarrhea (combined, 16.7%; single, 60.0%; and untreated,
57.1%). Moreover, the combined prophylaxis tended to shorten the periods of febrile
episodes defined as temperature > 38°C (combined, 3.8 days; single, 4.6 days; and
untreated, 5.6 days). It was concluded that combination of propantheline and oral
cryotherapy may be feasible and effective for reduction of mucosal toxicity in patients
with malignancy who undergo high-dose chemotherapy20.
A randomized clinical trial was conducted to compare the effectiveness of two different
durations of oral cryotherapy for prevention of 5- Fluorouracil related stomatitis. The
trial involved patients who were receiving their first course of a treatment regimen–
Fluorouracil plus leucoverin chemotherapy. These patients were randomized to receive
either 30 or 60 minutes of oral cryotherapy. They were instructed to place ice chips in
their mouth 5 minutes before to each dose of 5- Fluorouracil, continuously swish the
ice inside their mouth, and replenish the ice chips before the previous ice had
completely melted. This was done for a period of either 30 or 60 minutes. Evaluation
was done using physician judgement of mucositis and patient interview. Out of the total
178 patients evaluated it was found that both cryotherapy groups had similar degrees of
mucositis21.
A study was conducted to evaluate wether oral cryotherapy could delay or alleviate the
development of mucositis and thereby reduce the number of days with I.V. opioids
among
patients
who
receive
myeloablative
therapy
before
Bone
Marrow
Transplantation (BMT). Eighty patients 18 years and older, scheduled for BMT, were
included consecutively and randomised to oral cryotherapy or standard oral care. A
stratified randomisation was used with regard to type of transplantation. Intensity of
pain, severity of mucositis and use of opioids were recorded using pain visual analogue
scale (VAS) scores, mucositis index scores and medical and nursing charts. The study
results showed that patients receiving oral cryotherapy had less pronounced mucositis
and significantly fewer days with I.V. opioids than the control group22.
With a view to evaluate the effectiveness of prophylactic agents for oral mucositis in
patients receiving cancer treatment, the Cochrane Oral Health Group Trials Register,
the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and
EMBASE were searched and the results were given in the Cochrane Database of
Systematic Reviews.
Reference lists from relevant articles were scanned and the
authors of eligible studies were contacted to identify trials and obtain necessary
information. Information regarding methods, participants, interventions and outcome
measures and results were independently extracted, in duplicate, by two review authors.
Authors were contacted for details of randomisation and withdrawals and a quality
assessment was carried out. The Cochrane Collaboration statistical guidelines were
followed and risk ratios (RR) calculated using random-effects models. Out of the two
hundred and seventy-seven eligible studies ,33 interventions were included in the
trials,out of which 12 showed some evidence of a benefit for either preventing or
reducing the severity of mucositis. These included use of amifostine, antibiotic paste,
hydrolytic enzymes ,ice chips etc. Ice chips were found to prevent mucositis at all
levels RRs = 0.6423 .
EFFECT OF ORAL CRYOTHERAPY VERSUS SALINE IN REDUCING ORAL
MUCOSITIS
A clinical trial was conducted to evaluate the effectiveness of ice chips to prevent or
reduce oral mucositis in patients treated with high doses of Alkeran. The trial included
40 patients with multiple myeloma. Twenty-one patients received ice chips
(cryotherapy) 30 minutes prior to treatment and continued to use the ice chips for six
hours. Nineteen patients received normal saline instead of ice chips. Severe oral
mucositis occurred in 14% of patients treated with ice chips, compared with 74% of
patients treated with saline. Individuals treated with ice chips received fewer narcotics
and nutrition through a vein than those treated with saline.The researchers concluded
that cryotherapy significantly reduces the incidence of severe oral mucositis in patients
receiving treatment with high doses of Alkeran24.
A placebo controlled study comparing chlorhexidine and oral cooling with ice chips
was done in which 206 patients who received intravenous bolus 5- Fluorouracil with
leucoverin for 5 days were assigned randomly to one of three treatment namely
1) Chlorhexidine (.1% 15ml mouthwash for 1 minute 3 times daily for 3 weeks)
2) Placebo (normal saline with same taste additive as the chlorhexidine group)
3) Cryotherapy with crushed ice ( 10minutes before to 35 minutes after start of
chemotherapy)
The researchers found that both the chlorhexidine and cryotherapy treatments reduced
the frequency and duration of oral mucositis compared with normal saline
(chlorhexidine severity P<.01, duration P=.035; cryotherapy severity P<.005, duration
P=.003). It was pointed that while ice chips were easy and inexpensive to use, they are
drug and schedule dependent and cannot be used with 5-Flurouracil infusions or with
chemotherapy with long half lives25.
6.3 STATEMENT OF THE PROBLEM
A study to determine the effectiveness of oral ice cubes versus saline mouth wash on
the
prevention of oral mucositis in patients receiving chemotherapy
in selected
hospitals of Karnataka.
6.4 OBJECTIVES
The objectives of the study are:
1. To assess and compare the presence of oral mucositis among patients receiving
chemotherapy before and after the administration of oral ice cubes.
2. To assess and compare the presence of oral mucositis among patients receiving
chemotherapy before and after the administration of saline mouth wash.
3. To compare the effect of ice cubes versus saline mouth wash in terms of
presence or absence of oral mucositis.
4. To find the association of presence of oral mucositis among patients receiving
chemotherapy after administration of ice cubes with their selected personal
variables viz age, gender,education, occupation, income, other medications,
chemotherapeutic agents used and its dosage.
5. To find the association of presence of oral mucositis among patients receiving
chemotherapy after administration of saline mouth wash with their selected
personal variables viz age, gender,education,
occupation, income, other
medications, chemotherapeutic agents used and its dosage.
6.4.1 CONCEPTUAL / THEORETICAL FRAMEWORK
Pender’s health promotion model
6.4.2 OPERATIONAL DEFINITIONS

Chemotherapy – refers to the use of drug therapy to treat patients diagnosed
with cancer.

Oral mucositis – refers to the soreness and erythema of oral mucosa occurring
as a side effect of chemotherapy which can be assessed using W.H.O scale for
assessing mucositis and patient judged Mucositis grading scale.

Oral ice cubes – refers to the frozen plain water which takes the shape of the
container in which it is kept for freezing and whose corners are smoothened.

Saline mouth wash - 0.9% sodium chloride solution at room temperature.

Effectiveness – Reduction in the occurrence or absence of oral mucositis as
assessed by using W.H.O scale for assessing oral mucositis and patient oral
judged mucositis grading scale after the administration of ice cubes or saline
mouth wash.
6.5 HYPOTHESES
The following hypotheses are formulated for the study, and will be tested at .05 level of
significance.
H1 – There will be significant reduction in the occurrence of mucositis in patients
receiving chemotherapy after administration of ice cubes compared to patients in
control group
H2 - There will be significant reduction in the occurrence of mucositis in patients
receiving chemotherapy after administration of saline mouth wash compared to patients
in control group.
H3 - There will be significant difference in the occurrence of oral mucositis between
the patients receiving chemotherapy who were treated with ice cubes and those treated
with saline mouth wash .
H4 –. There will be significant association between occurrence of oral mucositis
among patients receiving chemotherapy after administration of ice cubes and their
selected personal variables viz age, gender,education,
occupation, income, other
medications, chemotherapeutic agents used and its dosage.
H5 - There will be significant association between occurrence of oral mucositis among
patients receiving chemotherapy after administration of saline mouth wash and their
selected personal variables viz age, gender,education,
medications, chemotherapeutic agents used and its dosage.
occupation, income, other
6.6 ASSUMPTIONS
The study assumes that
1. The patients receiving chemotherapy may develop mucositis as its side effect.
2. Using ice cubes or saline are non pharmacological measures of preventing
mucositis among patients receiving chemotherapy.
3. Oral cooling reduces the distribution of the chemotherapy agent to the oral
mucosa by causing vasoconstriction.
6.7 DELIMITATIONS
Study is limited to patients receiving chemotherapy for cancer in selected hospitals of
Karnataka.
Study is limited to assessment of oral mucosa by W.H.O scale for assessing mucositis
and patient judged Mucositis grading scale
7.0 MATERIAL AND METHODS:
RESEARCH DESIGNS AND APPROACH:
Non-equivalent pretest post test control group quasi experimental research design
E1
O1
x
O2
(ice-cubes)
E2
O1
x
O2
(saline mouth wash)
C
O1
-
O2
VARIABLES OF THE STUDY
Independent variable: Use of ice cubes or saline mouth wash.
Dependent variable: Oral mucositis.
Extraneous variables : Selected personal variables viz age, gender, education
religion, occupation, income, other medications and the chemotherapeutic agent used
and its dosage.
7.1 SOURCE OF DATA
Settings: selected hospitals of Karnataka
Population : patients receiving chemotherapy in selected hospitals
7.2 METHOD OF COLLECTION OF DATA (INCLUDING
SAMPLING PRODEDURE, IF ANY):
SAMPLE AND SAMPLING CRITERIA
Inclusion criteria: Patients receiving chemotherapy who are :
1. available during the period of data collection and not having oral mucositis.
2. willing to participate and between 18 years to 65 years of age.
Exclusion criteria: Patients receiving chemotherapy who are :
1. not willing to participate in the study
2. less than 18 years and more than 65 years of age.
SAMPLING TECHNIQUE: Non-probability convenience sampling
SAMPLE SIZE: 90 patients receiving chemotherapy, 30 patients in experimental
group-1 receiving ice-cubes during chemotherapy, 30 patients in experimental group-2
receiving saline mouthwash during chemotherapy and 30 patients in control group.
DATA COLLECTION TECHNIQUES: Using patient judged Mucositis grading7
and observation using W.H.O. oral mucositis assessment scale26.
GRADE
0
1
2
3
4
None Soreness
WHO
Erythema,
Ulcers
with Mucositis
± erythema ulcers,
and extensive
to
patient
can erythema
that
swallow
and
solid food
cannot
the
extent
alimentation
patient is not possible
swallow
solid food
Patient-
None Mild
Judged
Definite
Marked
discomfort discomfort but discomfort
Mucositis
able to eat solid interfered
grading
food.
Marked discomfort
that that
prevented
with taking fluid or food
eating solid food by
mouth
thus
requiring
intravenous feeding
METHOD OF DATA COLLECTION:
1. Approval from authority.
2. Select sample as per criteria and obtain informed consent.
3. Assess the oral mucosa for presence or absence of oral mucositis.
4. Assign patients to be either in control group, or to receive ice cubes or to get
saline
mouth wash.
5. Administer ice cubes to Experimental group- 1, 5 minutes prior to, maintained
during infusion/ injection and 15 minutes after injection of chemotherapeutic agent.
6. Administer normal saline mouth wash to Experimental group- 2, 15 ml over 30
seconds at a rate of every 5 minutes, starting 15 minutes prior to initiation of
chemotherapy maintained during infusion and 15 minutes after injection of
chemotherapeutic agent
7. Explain to patients to use patient – judged mucositis grading scale to record daily
the severity of mucositis from the day of first chemotherapy to 10 days after
chemotherapy
8. Assess the oral cavity of patients in all three groups for presence of mucositis after
10 days of chemotherapy using W.H.O. assessment scale for oral mucositis.
PLAN OF DATA ANALYSIS:
Descriptive statistical analysis.
Frequency and percentage will be used to describe the characteristics of study sample.
Inferential statistical analysis

Independent ‘t’ test will be used to compare the effectiveness of ice cubes and
saline in preventing oral mucositis.

Chi-square will be used to find significant association of occurrence of oral
mucositis with use of ice-cubes or saline

Chi-square will be used to find significant association of severity of mucositis
with the personal variables of patients viz age, gender, education,occupation,
income and the chemotherapeutic drug and its dosage.
7.3 Does the study requires any investigation or intervention to be conducted on
patients or other humans or animals? If so, please describe briefly.
No
7.4 Has ethical clearance been obtained from your institution in case of 7.3.
Yes, ethical clearance has been obtained from our institution
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available
at
9.0
SIGNATURE OF THE CANDIATE:
REMARKS OF THE GUIDE:
11.0 NAME AND DESIGNATION OF GUIDE (in block letters)
DR. BHARTI.M
PRINCIPAL
J.S.S COLLEGE OF NURSING, I MAIN, SARASWATHIPURAM,
MYSORE.
11.2
SIGNATURE:
HEAD OF THE MEDICAL SURGICAL NURSING DEPARTMENT
DR. BHARTI.M
PRINCIPAL
J.S.S COLLEGE OF NURSING, I MAIN, SARASWATHIPURAM,
MYSORE.
11.4
SIGNATURE
REMARKS OF THE CHAIRMAN AND PRINCIPAL:
DR. BHARTI. M.
PROFESSOR AND PRINCIPAL
J.S.S COLLEGE OF NURSING, I MAIN, SARASWATHIPURAM,
MYSORE.
12.2
SIGNATURE