Download NOSCAN Diarrhoea Guidelines

GUIDELINES FOR MANAGEMENT OF SYSTEMIC
ANTI-CANCER THERAPY INDUCED DIARRHOEA IN
ADULT HAEMATOLOGY AND ONCOLOGY PATIENTS
Lead Author/Co-ordinator:
Reviewer:
Approver:
NOSCAN Systemic AntiCancer Therapy Advisory
Group (NSAG)
Mark Parsons
Chair, NSAG
Signature:
Signature:
Signature:
Identifier:
(to be provided after
sign-off)
Approval Date:
October 2015
Review Date:
October 2017
Leanne Miller
Uncontrolled When Printed
Version [1]
Contents
1.
Introduction
………………………………………………………
Page
No.
3
2.
Area of Application
………………………………………………………
3
3.
Points to Consider
………………………………………………………
3
4.
Initial Assessment
………………………………………………………
3
5.
Management
………………………………………………………
6
6.
Capecitabine
………………………………………………………
6
7.
Fluorouracil (5-FU)
………………………………………………………
7
8.
Irinotecan
………………………………………………………
7
9.
Ipilimumab
………………………………………………………
7
10. References
………………………………………………………
9
Guidelines for Management of Systemic Anti-Cancer
Therapy (SACT) Induced Diarrhoea in Adult Haematology
and Oncology Patients
[Version Number 1]
Approved: [October 2015]
Review date: [October 2015]
Page 2 of 10
Guidelines for Management of Systemic Anti-Cancer Therapy (SACT) Induced
Diarrhoea in Adult Haematology and Oncology Patients
1. Introduction
Diarrhoea is the passage of frequent loose stools with urgency. It can be defined as the
passage of more than three unformed stools within a 24 hour period but is relative to normal
baseline function. SACT induced diarrhoea is most likely to occur in the first 7 days post
SACT.
2. Area of Application
This policy applies to all adult SACT services across the NOSCAN region, excepting for the
administrative areas of Argyll and Bute in NHS Highland which are linked to the WOSCAN
CEL (2012) 30 governance framework.
3. Points to Consider
a. Medication: laxatives, antacids, iron, antibiotics, non-steroidal anti-inflammatory drugs
(NSAIDs), SACT
b. Radiotherapy, particularly when involving the abdomen or pelvis
c. Faecal impaction can result in diarrhoea as overflow
d. Obstruction: malignant faecal impaction, narcotic bowel syndrome (severe constipation
caused by opioid analgesia).
e. Disease related – pancreatic carcinoma, pancreatic islet tumours, carcinoid tumours
f. Concurrent disease, for example diabetes mellitus, hyperthyroidism, pancreatic
insufficiency, inflammatory bowel disease such as Crohn’s disease, ulcerative colitis
g. Infection
4. Initial Assessment
• What SACT is the patient on and when was the last treatment/tablet?
• CAPECITABINE, FLUOROURACIL, IRINOTECAN and IPILIMUMAB require specific
management – see information below.
• Is patient receiving concurrent radiotherapy and when was last treatment? Discuss with
Radiotherapy team during working hours
• Is the patient participating in a clinical trial – Contact Clinical Trial team during working
hours
• Frequency of diarrhoea and information about patient’s normal baseline
• How long have they had diarrhoea
• What colour is diarrhoea? (brown fluid is likely to be treatment related, yellow/green
indicates infective and specimen should be taken)
• Is there any blood in the stool
Guidelines for Management of Systemic Anti-Cancer
Therapy (SACT) Induced Diarrhoea in Adult Haematology
and Oncology Patients
[Version Number 1]
Approved: [October 2015]
Review date: [October 2015]
Page 3 of 10
•
•
•
•
•
Is the patient taking any new medication? If yes, what?
Has the patient eaten anything different?
Is there an associated temperature?
Has patient recently been constipated?
Grade toxicity as per Table 1.
Consider infective diarrhoea if:
Refractory grade 2 diarrhoea (see below for definition), recent hospital admission, antibiotics
or previous Clostridium Difficile (C.diff) infection:
• Send stool urgently.
• If strong suspicion of infective diarrhoea, withhold anti-diarrhoeal medication until
stool result available.
o Stop proton pump inhibitors where possible, consider H2-receptor antagonist e.g.
ranitidine
• Prescribe antibiotics for treatment of C.diff as per local policy
Consider dehydration if: Patient reports dry mouth, fatigue, thirst, decreased urine
output, headache or feeling dizzy or light headed. Patients with extreme dehydration
can also have symptoms of irritability or confusion.
Guidelines for Management of Systemic Anti-Cancer
Therapy (SACT) Induced Diarrhoea in Adult Haematology
and Oncology Patients
[Version Number 1]
Approved: [October 2015]
Review date: [October 2015]
Page 4 of 10
Table1: Toxicity grading
Grade 1
Increase of <4 stools
per day over baseline;
mild increase in ostomy
output compared to
baseline
TOXICITY GRADING (Document in patient’s case notes / nursing notes)
Grade 2
Grade 3
Grade 4
Increase of 4 - 6 stools per day
Increase of >=7 stools per day over baseline;
Life-threatening consequences; urgent intervention
over baseline; moderate increase in incontinence; hospitalization indicated; severe
indicated
ostomy output compared to
increase in ostomy output compared to baseline;
baseline
limiting self care ADL
Systemic Anti-cancer therapy (SACT) including oral chemotherapy should be withheld until discussion with Haematology/Oncology team
Antimotility drugs not
normally required for
Grade 1
If patient also has
associated
temperature,
nausea/vomiting, sore
mouth/throat,
dizziness,
confusion or other
clinical concerns –
needs medical
review/admission
Initiate loperamide - if ineffective,
try codeine
Admit patient urgently (unless clinical review suggests no concerns, well hydrated, has not yet had
antidiarrhoeals and able to review patient daily).
If Grade 2 for >24hours maximal
antidiarrhoeal treatment – admit for
assessment/admission
History to include other chemotherapy toxicities (risk of damage to rest of GI tract and skin –manage nausea/
mucositis /sepsis/hand-foot syndrome according to local guidelines)
Assessment of fluid balance status (BP, pulse etc) and signs of systemic infection
Reduce/stop antidiarrhoeal
medication after 24 hours free of
diarrhoea.
Fluid resuscitation and electrolyte replacement where indicated
Stop ACE-inhibitors/ Angiotensin-II inhibitors /diuretics/ NSAIDs /metformin
If patient also has associated
temperature,
nausea/vomiting, sore
mouth/throat, dizziness,
confusion or other clinical
concerns –
needs medical review/admission
Daily bloods (U&Es, FBC, CRP, magnesium, albumin, blood cultures if signs of systemic sepsis), SEWS,
cumulative fluid balance
Stool sample (send for urgent culture, C diff toxin and viral screen - discuss with Microbiology)
Consider abdominal XR to exclude ileus/ obstruction/ perforation /megacolon
Dietician review if appropriate
Guidelines for Management of Systemic Anti-Cancer
Therapy (SACT) Induced Diarrhoea in Adult Haematology and Oncology Patients
[Version Number 1]
Approved: [October 2015]
Review date: [October 2017]
Page 5 of 10
5. Management
See Table 1 for initial management according to grade of diarrhoea.
General Advice
• If diarrhoea lasts > 48 hours, or if the patient reports symptoms of dehydration
or fever, they should be reviewed/admitted as a matter of urgency and admitted
to hospital for further management if necessary.
• Increase oral fluids (2-3 L per day), avoid caffeinated drinks and alcohol
• Avoid milk, high-fat foods, raw fruit and vegetables, beans, fibrous vegetables,
cereals
• Suggest bananas, rice, noodles, white bread, crackers, skinned chicken, white fish.
• Ensure anal area is kept clean and intact by regular washing and application of
barrier cream (for patient not undergoing concurrent chemo radiotherapy). Some
barrier creams contain ingredients contraindicated in radiotherapy.
• Stop any medication that may be contributing e.g. laxatives, domperidone,
metoclopramide, magnesium containing antacids
Pharmacological Management
Where there is concern that cause may be infective anti-motility agents should be not
be commenced until negative cultures have been obtained.
Table 2: Oral dose of drugs
Treatment
choice
st
1 line
Drug
Loperamide
Indication
Oral Dose
Antimotility
4mg initially then 2mg after each loose
stool (maximum 16mg/24 hours)*
nd
2 line
Codeine
Antimotility
30-60mg every four hours when required
phosphate
(maximum 240mg/24hours)
* If not controlling diarrhoea rapidly, change to 2mg four times a day. This can be increased to 4mg
four times a day if required.
6. Capecitabine
Table 3: Capecitabine dose modification
Diarrhoea
Grade 2
st
1
Interrupt treatment until
appearance resolved to grade 0-1,
then continue at same dose
with antidiarrhoeal treatment
where possible
nd
2
Interrupt treatment until
appearance resolved to grade 0-1,
then reduce dose by 25% with
antidiarrhoeal treatment where
possible
rd
3
Interrupt treatment until
appearance resolved to grade 0-1,
then reduce original dose by
50% with antidiarrhoeal
treatment where possible
th
4
Discontinue treatment
appearance
Grade 3
Interrupt treatment until
resolved to grade 0-1, then
reduce dose by 25% with
antidiarrhoeal treatment where
possible
Interrupt treatment until
resolved to grade 0-1,
then reduce original dose by
50% with antidiarrhoeal
treatment where possible
Discontinue treatment
Grade 4
Discontinue
treatment
Guidelines for Management of Systemic Anti-Cancer
Therapy (SACT) Induced Diarrhoea in Adult Haematology and Oncology Patients
[Version Number 1]
Approved: [October 2015]
Review date: [October 2017]
Page 6 of 10
7. Fluorouracil (5-FU)
Diarrhoea – can occur in approximately 50% of patients on 5-FU and moderate/severe
diarrhoea should be treated with loperamide. In some cases dose reduction may be
necessary
• At the first loose stool, loperamide should be commenced.
If grade ≥2 diarrhoea from the previous cycle, has not resolved by the time the next
cycle is due despite treatment, delay treatment by 1 week.
8. Irinotecan
Irinotecan can cause both early (acute) and delayed diarrhoea. Early diarrhoea is caused by
an acute cholinergic syndrome which can occur shortly after infusion of irinotecan and
includes symptoms such as diarrhoea, sweating, abdominal cramping, myosis and salivation.
Atropine sulphate (0.25 mg subcutaneously) should be administered unless clinically
contraindicated when this occurs and should be used prophylactically for future cycles.
Delayed diarrhoea may start from Day 3 (22% incidence) and if untreated, may become
severe. The incidence of diarrhoea is significantly reduced by the early and aggressive use of
loperamide.
• At the first loose stool, loperamide should be commenced: 4mg (2 tablets), then 2mg
every 2 hours until 12 hours after the last loose stool (up to a maximum of 48 hours) (Note
this exceeds licensed dose).
• If diarrhoea lasts more than 24 hours, ciprofloxacin 500mg twice daily should be
started, in addition to loperamide.
If diarrhoea lasts > 48 hours, or if the patient reports symptoms of dehydration or fever,
they should be admitted immediately to hospital for rehydration and further management,
including an infection screen. Loperamide and ciprofloxacin are supplied routinely with
Irinotecan chemotherapy.
The occurrence of severe diarrhoea concomitantly with severe neutropenia is lifethreatening, requiring immediate admission to hospital and the institution of supportive
measures.
After an episode of severe diarrhoea (e.g. grade ≥3 or requiring admission), delay
further treatment until full recovery then resume irinotecan with a 20% dose reduction.
If grade ≥2 diarrhoea from the previous cycle has not resolved by the time the next
cycle is due, delay treatment by 1 week.
9. Ipilimumab
Ipilimumab is associated with serious immune-related gastrointestinal reactions. Median
time to onset of severe or fatal (grade 3-5) reactions is 8 weeks from the start of
treatment. However symptoms can occur weeks or months after treatment is
discontinued.
Guidelines for Management of Systemic Anti-Cancer
Therapy (SACT) Induced Diarrhoea in Adult Haematology
and Oncology Patients
[Version Number 1]
Approved: [October 2015]
Review date: [October 2015]
Page 7 of 10
Clinical presentation may include diarrhoea, increased frequency of bowel movements,
abdominal pain, or haematochezia (bright red blood in stool), with or without fever. Diarrhoea
or colitis occurring after initiation of ipilimumab must be promptly evaluated to exclude
infectious or other alternate causes. Note - dose reduction is not recommended.
Table 4: Management ipilimumab-induced diarrhoea
Grade 1-2
Moderate diarrhoea or colitis that either is
not controlled with medical management or
that persists (5-7 days) or recurs
Grade 3-4
Severe symptoms (abdominal pain, severe
diarrhoea or significant change in the
number stools, blood in stool, gastrointestinal
haemorrhage, gastrointestinal perforation)
Withhold dose until adverse reaction
resolves to grade 1 or grade 0 (or returns to
baseline)
Permanently discontinue ipililumab
Evaluate patients for evidence of perforation
or peritonitis
Initiate loperamide
Fluid replacement if necessary
If resolution occurs, resume therapy at next
scheduled dose*
If resolution has not occurred, continue to
withhold doses until resolution then resume
treatment*
Discontinue ipililumab if resolution to grade 1
or grade 0 or return to baseline does not
occur
If mild to moderate symptoms recur or
persist for 5-7 days, the scheduled dose of
ipililumab should be withheld and
prednisone 1mg/kg orally once daily
should be initiated
IV methylprednisolone 2mg/kg/day should
be initiated immediately (avoid if bowel
perforation is present)
Once diarrhoea and other symptoms are
controlled, the initiation of corticosteroid
(over 6-8 weeks). In clinical trials, rapid
tapering (over period < 1 month) resulted in
recurrence of diarrhoea or colitis in some
patients
Consider alternative immunosuppressive
therapy (single dose of infliximab 5mg/kg) if
symptoms do not respond to steroids in 5-7
days – discuss with GI specialist before
initiating infliximab.
*until administration of all 4 doses or 16
weeks from first dose, whichever occurs
earlier
Guidelines for Management of Systemic Anti-Cancer
Therapy (SACT) Induced Diarrhoea in Adult Haematology
and Oncology Patients
[Version Number 1]
Approved: [October 2015]
Review date: [October 2015]
Page 8 of 10
10. References
• National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE),
•
•
•
•
Version 4. 28th May 2009
NHS Highland Cancer Chemotherapy Protocol – Capecitabine 23/05/13.
NHS Highland Cancer Chemotherapy Protocol – FOLFIRI 31/10/12.
NHS Highland Formulary, 5th Edition.
NHS TAYSIDE Cancer chemotherapy protocol- Degramont chemotherapy
• Scottish Palliative Care Guidelines
http://www.palliativecareguidelines.scot.nhs.uk/guidelines/symptomcontrol/Diarrhoea.aspx Accessed 06/06/15
• South East Scotland Cancer Network. Management of Chemotherapy Toxicity
Guidelines – Diarrhoea 2010.
• Summary of Product Characteristics for individual drugs – www.medicines.org
Accessed 06/06/15.
• UKONS Acute Oncology Initial Management Guidelines 2013
Guidelines for Management of Systemic Anti-Cancer
Therapy (SACT) Induced Diarrhoea in Adult Haematology
and Oncology Patients
[Version Number 1]
Approved: [October 2015]
Review date: [October 2015]
Page 9 of 10
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Guidelines for Management of Systemic Anti-Cancer
Therapy (SACT) Induced Diarrhoea in Adult Haematology
and Oncology Patients
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[Version Number 1]
Approved: [October 2015]
Review date: [October 2015]
Page 10 of 10