Download Strength of recommendation

ESPEN Congress Geneva 2014
ESPEN GUIDELINES
ESPEN Guidelines: nutrition support in cancer
J. Arends (DE)
espen and epaac guidelines
nutrition in cancer
Jann Arends
Tumor Biology Center Freiburg
¾ Ethical dilemmas
¾ Bioethical principles
¾ Application of bioethical
principles to “Nutrition at the endof-life”
¾ The decision-making process
ESPEN GL Oncology
sponsors
2009‐2014
ESPEN GL Oncology
ESPEN GL Oncology
aim of the guideline
Translate current evidence and expert opinion into recommendations for the multi‐disciplinary team responsible for prevention, identification and treatment of reversible elements of malnutrition in cancer patients and contribute to decreasing the risk of cancer recurrence.
ESPEN GL Oncology
Guideline: Problems
Evidence of high quality is very limited
Recommendations triggered solely by the level of evidence
are not helpful for clinical practice
ESPEN Cancer‐GL 2006&2009
AGREE rating of applicability:
[van den Berg T et al. JPEN 2011]
0‐7/100
ESPEN GL Oncology
Evidence J Recommendations: GRADE
Level of evidence:
RCT: Observ. Study:
Expert opinion:
adjusting for:
initially
high
low
very low
after adjustment
very low .. high
very low .. high
very low
Ž study quality, inconsistencies, indirectness, imprecision, bias
« magnitude of effect, dose‐response relationship
Strength of recommendation
STRONG:
desirable effects clearly outweigh harms
WEAK:
trade‐offs are uncertain
ESPEN disease‐specific guideline framework. Preiser JC & Schneider SM, Clin Nutr 2011
Grading quality of evidence and strength of recommendations. Oxman AD et al., Br Med J 2004
GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. Guyatt GH et al., Br Med J 2008
ESPEN GL Oncology
time frame and methodology
2011 ‐ 2014
20 experts, 2 ESPEN leaders, 2 methodologists
evidence search and GRADE technique*
recommendations consensus process
Æ online review, ESPEN website
*ESPEN disease‐specific guideline framework; Clin Nutr 2011
ESPEN GL Oncology
outline
0
Methods
Goals, target population, professional groups involved
patient views, target users, conflict of interest and funding
design, searches, recommendations, consensus
professional review, updating of GL
facilitators/barriers, costs, monitoring/auditing
A
Introduction
Major alterations in cancer patients
effects on clinical outcome
aims of nutritional interventions
B
General concepts – relevant to all cancer patients
C
Interventions relevant to specific patient categories
ESPEN GL Oncology
outline
0
Methods
A
Introduction
B
General concepts – relevant to all cancer patients
B1
Screening and assessment
B2
Energy and substrate requirements
B3
Nutritional interventions
B4
Physical exercise
B5
Pharmacological agents
C
Interventions relevant to specific patient categories
ESPEN GL Oncology
outline
0
Methods
A
Introduction
B
General concepts – relevant to all cancer patients
C
Interventions relevant to specific patient categories
C1
Surgery
C2
Radiotherapy
C3
Curative medical anticancer treatment
C4
High‐dose chemotherapy and HSCT
C5
Cancer survivors
C6
Incurable cancer patients
ESPEN GL Oncology
Section B1, Statement 1
B1 ‐ 1
Screening
Strength of recommendation
To detect nutritional disturbances at an early stage, we recommend to regularly evaluate nutritional intake, weight change and BMI, beginning with cancer diagnosis and repeated depending on the stability of the clinical situation. STRONG
Level of evidence
Questions for research
Very low
relationship of screening to assessment
interventions and clinical outcomes
ESPEN GL Oncology
Section B1, Statement 2
B1 ‐ 2
Assessment
Strength of recommendation
In patients with abnormal screening, we recommend objective and quantitative assessment of nutritional intake, nutrition impact symptoms, physical performance and the degree of systemic inflammation. STRONG
Level of evidence
Questions for research
Very low
Linking outcomes from current and future intervention trials with appropriate screening and assessment tools
ESPEN GL Oncology
Section B2, Statement 1
B2 ‐ 1
Energy requirements
Strength of recommendation
We recommend, for practical purposes, that total energy expenditure of cancer patients, if not measured individually, be assumed to be rather similar to healthy subjects and ranging between 25 and 30 kcal/kg/day. STRONG
Level of evidence
Questions for research
Low
improve prediction of energy requirements in the individual patient
ESPEN GL Oncology
Section B2, Statement 2
B2 ‐ 2
Protein intake
Strength of recommendation
We suggest that protein intake should be above 1 g/kg/day and if possible up to 1.5 g/kg/day WEAK
Level of evidence
Questions for research
Moderate
effect on outcome of increased supply and composition of protein/amino acids ESPEN GL Oncology
Section B2, Statement 3
B2 ‐ 3
Choice of energy substrates
Strength of recommendation
In most patients general recommendations are applicable. In weight‐losing patients with advanced cancer we recommend a fat intake of 35‐50% of total energy requirement. STRONG
Level of evidence
Questions for research
Low
effect of high fat on outcome in specific patient groups
ESPEN GL Oncology
Section B2, Statement 4
B2 ‐ 4
Vitamins and trace elements
Strength of recommendation
We recommend that vitamins and minerals be supplied in amounts approximately equal to the RDA and discourage the use of high‐dose micronutrients in the absence of specific deficiencies.
STRONG
Level of evidence
Questions for research
Low
Assessment of micronutrient status in cancer patients and effect of
supplementation
ESPEN GL Oncology
Section B3, Statement 1
B3 ‐ 1
Efficacy of nutritional intervention
Strength of recommendation
We recommend nutritional intervention to increase oral intake in cancer patients who are able to eat but are malnourished or at risk of malnutrition. This includes dietary advice, the treatment of symptoms and derangements impairing food intake, and offering oral nutritional supplements.
STRONG
Level of evidence
Questions for research
Moderate
effect of advice and ONS on outcome
ESPEN GL Oncology
Section B3, Statement 2
B3 ‐ 2
Low efficacy of special diets
Strength of recommendation
We recommend against dietary provisions like “anticancer diets” which restrict energy intake in patients with or at risk
of malnutrition. STRONG
Level of evidence
Low
Questions for research
ESPEN GL Oncology
Section B3, Statement 3
B3 ‐ 3
Modes of nutrition
Strength of recommendation
We recommend enteral nutrition if oral nutrition remains inadequate despite nutritional interventions, and parenteral
nutrition if enteral nutrition is not sufficient or feasible.
STRONG
Level of evidence
Questions for research
Moderate
effect of EN or PN or combinations on outcome
ESPEN GL Oncology
Section B3, Statement 4
B3 ‐ 4
Refeeding syndrome
Strength of recommendation
If oral food intake has been decreased severely for a prolonged period of time, we recommend to increase enteral
or parenteral nutrition only slowly over several days and to take additional precautions to prevent a refeeding syndrome.
STRONG
Level of evidence
Questions for research
Low
Assessment of phosphate, potassium and magnesium levels in malnourished
cancer patients and response to artificial feeding
ESPEN GL Oncology
Section B3, Statement 5
B3 ‐ 5
Home artificial nutrition
Strength of recommendation
In patients with chronic insufficient dietary intake and/or uncontrollable malabsorption we recommend home artificial nutrition in suitable patients
STRONG
Level of evidence
Questions for research
Low
Effect of long‐term EN and PN on clinical outcome
ESPEN GL Oncology
Section B4, Statement 1
B4 ‐ 1
Exercise in combination with nutrition
Strength of recommendation
We recommend maintenance or increased level of physical activity in cancer patients during and after treatment to support muscle mass, physical function and metabolic pattern.
STRONG
Level of evidence
Questions for research
High
effect of physical activity on outcome
ESPEN GL Oncology
Section B4, Statement 2
B4 ‐ 2
Type of exercise recommended
Strength of recommendation
We suggest individualized resistance exercise to maintain muscle strength and muscle mass during treatment. WEAK
Level of evidence
Questions for research
Low
effect of resistance and endurance exercise on outcome
ESPEN GL Oncology
Section B5, Statement 1
B5 ‐ 1
Corticosteroids to increase appetite
Strength of recommendation
We suggest to consider using corticosteroids to increase the appetite of anorectic cancer patients for a restricted period of time but to be aware of potential side effects (e.g. muscle
wasting).
WEAK
Level of evidence
Questions for research
High
Methods to counteract corticosteroid‐related muscle wasting
ESPEN GL Oncology
Section B5, Statement 2
B5 ‐ 2
Progestins to increase appetite
Strength of recommendation
We suggest to consider using progestins to increase the appetite of anorectic cancer patients for a limited period of time but to be aware of potential serious side effects.
WEAK
Level of evidence
Questions for research
High
Prospective studies to evaluate the combined effects of appropriate
nutritional support and progestins
ESPEN GL Oncology
Section B5, Statement 3
B5 ‐ 3
Cannabinoids to improve appetite
Strength of recommendation
We suggest to consider cannabinoids to attempt to improve taste disorders and anorexia in cancer patients
WEAK
Level of evidence
Questions for research
Low
Effects of cannabinoids on nutritional state in anorectic cancer patients with
taste alterations
ESPEN GL Oncology
Section B5, Statement 4
B5‐ 4
Androgens to increase muscle mass
Strength of recommendation
There are insufficient data to recommend on androgenic steroids to increase muscle mass
NONE
Level of evidence
Questions for research
High
Mechanism and long term effects of SARMs in patients with cachexia.
ESPEN GL Oncology
Section B5, Statement 5
B5 ‐ 5
Amino acids
Strength of recommendation
There is not enough clinical data to recommend the supplementation with branched‐chain amino acids or metabolites to improve fat free mass.
NONE
Level of evidence
Questions for research
Low
Effects of leucine or HMB (hydroxy methylbutyrate) in weight losing patients
studied in large randomized trials
ESPEN GL Oncology
Section B5, Statement 6
B5 ‐ 6
Non steroidal antiinflammatory drugs
Strength of recommendation
There is not enough data to recommend non‐steroidal antiinflammatory drugs to improve body weight in weight losing cancer patients. NONE
Level of evidence
Questions for research
Low
Effect of NSAIDs on body composition and clinical outcome in cancer patients
with systemic inflammation
ESPEN GL Oncology
Section B5, Statement 7
B5 ‐ 7
N‐3 fatty acids to improve appetite and body weight
Strength of recommendation
In cancer patients undergoing chemotherapy at risk of weight loss, we suggest to use the supplementation with long‐chain n‐3 fatty acids or fish oil to stabilize/improve appetite, food intake, lean body mass and body weight.
WEAK
Level of evidence
Questions for research
Moderate
Effect of long‐chain N‐3 fatty acids on body composition and clinical outcome
in cancer patients undergoing antineoplastic treatment
ESPEN GL Oncology
Section C1, Statement 1
C1 ‐ 1
Enhanced recovery after surgery (ERAS) care
Strength of recommendation
For all cancer patients undergoing either curative resectional
or palliative surgery we recommend management within an enhanced recovery after surgery program.
STRONG
Level of evidence
Questions for research
High
optimal components including nutrition of ERAS protocol for oncology patients
ESPEN GL Oncology
Section C1, Statement 2
C1 ‐ 2
Surgery: Multimodal oncological pathway
Strength of recommendation
For a patient undergoing repeated surgery as part of a multimodal oncological pathway, management of each surgical episode should be within an ERAS programme.
STRONG
Level of evidence
Questions for research
Low
role of multimodal rehabilitation during prolonged oncological therapy
ESPEN GL Oncology
Section C1, Statement 3
C1 ‐ 3
Surgery: Care after hospital discharge
Strength of recommendation
In surgical cancer patients at moderate or severe nutritional risk we recommend appropriate ONS/enteral nutritional support both before and following discharge from hospital.
STRONG
Level of evidence
Questions for research
Moderate
The role of immunonutrition when upper GI cancer patients are managed within an ERAS pathway. The optimal post‐operative regimen in terms of type, preparation and access to normal food +/‐ oral nutritional supplements for patients managed within an ERAS pathway.
The role of n‐3 enriched oral supplements/enteral nutrition in upper GI cancer patients for preservation of lean body mass and optimisation of organ function.
ESPEN GL Oncology
Section C1, Statement 4
C1 ‐ 4
Traditional peri‐operative care
Strength of recommendation
In upper GI cancer patients undergoing surgical resection in the context of traditional perioperative care we recommend oral/enteral immunonutrition.
STRONG
Level of evidence
Questions for research
High
Role of immunonutrition for upper GI cancer patients managed within an ERAS pathway
ESPEN GL Oncology
Section C2, Statement 1
C2 ‐ 1
RT: Ensuring adequate nutritional intake
Strength of recommendation
We recommend that during RT to the head‐neck, upper and low GI tract and thorax, an adequate nutritional intake should be ensured primarily by individualized nutritional counseling and/or with use of ONS, in order to avoid nutritional deterioration, maintain intake and avoid RT interruptions
STRONG
Level of evidence
Moderate
Questions for research
ESPEN GL Oncology
Section C2, Statement 2
C2 ‐ 2
RT: Use of tube feeding
Strength of recommendation
We recommend that tube feeding may be done using transnasal or PEG in RT‐induced severe mucositis or in head‐
neck/throracic cancers with obstructive tumor masses.
STRONG
Level of evidence
Low
Questions for research
ESPEN GL Oncology
Section C2, Statement 3
C2 ‐ 3
RT: Maintaining swallowing function
Strength of recommendation
We recommend that patients should be encouraged and educated on how to maintain their swallowing function during EN. STRONG
Level of evidence
Low
Questions for research
ESPEN GL Oncology
Section C2, Statement 4
C2 ‐ 4
Radiation‐induced diarrhea: glutamine
Strength of recommendation
We do not recommend using glutamine during pelvic RT to prevent RT‐induced enteritis/diarrhea. STRONG
Level of evidence
Low
Questions for research
ESPEN GL Oncology
Section C2, Statement 5
C2 ‐ 5
Radiation‐induced diarrhea: probiotics
Strength of recommendation
There is not enough data to recommend Lactobacillus‐
containing probiotics to reduce radiation‐induced diarrhea.
NONE
Level of evidence
Low
Questions for research
ESPEN GL Oncology
Section C2, Statement 6
C2 ‐ 6
RT: Use of parenteral nutrition
Strength of recommendation
Parenteral nutrition (PN) is not recommended in general in RT; it should only be initiated if adequate oral/enteral
nutrition is not possible, e.g. severe RT enteritis, severe mucositis or head‐neck/oesophageal obstructive cancer masses.
STRONG
Level of evidence
Moderate
Questions for research
ESPEN GL Oncology
Section C3, Statement 1
C3 – 1
Medical anticancer treatment: Ensuring adequate nutrition
Strength of recommendation
During anticancer drug treatment we recommend to ensure an adequate nutritional intake and to maintain physical activity. STRONG
Level of evidence
Very low
Questions for research
ESPEN GL Oncology
Section C3, Statement 2
C3 – 2
Medical anticancer treatment: Use of artificial nutrition
Strength of recommendation
If oral food intake is inadequate despite counselling and ONS, we recommend to initiate enteral or, if this is not sufficient or possible, parenteral nutrition.
STRONG
Level of evidence
Very low
Questions for research
ESPEN GL Oncology
Section C3, Statement 3
C3 – 3
Medical anticancer treatment: use of glutamine
Strength of recommendation
There is insufficient evidence to recommend glutamine supplementation during conventional cytotoxic or targeted therapy.
NONE
Level of evidence
Low
Questions for research
ESPEN GL Oncology
Section C3, Statement 4
C3 – 4
Medical anticancer treatment: fish oil
Strength of recommendation
For oncological outcomes there is insufficient evidence to recommend for or against fish oil supplementation during chemotherapy. NONE
Level of evidence
Questions for research
Low
Effects of long‐chain N‐3 fatty acids on the therapeutic index of chemotherapy
ESPEN GL Oncology
Section C4, Statement 1
C4 – 1
HSCT: ensuring adequate nutrition and physical activity
Strength of recommendation
During high‐dose anticancer drug treatment and stem cell transplantation we recommend to maintain physical activity and to ensure an adequate nutritional intake. This may often require artificial nutrition.
STRONG
Level of evidence
Questions for research
Very low
Effects of physical actvity on clinical outcome
ESPEN GL Oncology
Section C4, Statement 2
C4 – 1
HSCT: Artificial nutrition
Strength of recommendation
If artificial nutrition is required we suggest to prefer enteral
tube feeding over parenteral nutrition, unless there is severe mucositis or symptomatic gastrointestinal GvHD. WEAK
Level of evidence
Low
Questions for research
ESPEN GL Oncology
Section C4, Statement 3
C4 – 3
HSCT: Germ‐free food
Strength of recommendation
There is not enough evidence to recommend germ‐free food for patients more than 30 days after allogeneic
transplantation
NONE
Level of evidence
Low
Questions for research
ESPEN GL Oncology
Section C4, Statement 4
C4 – 4
HSCT: glutamine
Strength of recommendation
There is not enough evidence to recommend for or against glutamine to reduce anticancer therapy side effects especially in high dose protocols.
NONE
Level of evidence
Low
Questions for research
ESPEN GL Oncology
Section C5, Statement 1
C5 – 1
Cancer survivors: Physical activity
Strength of recommendation
We recommend that cancer continue to engage in regular physical activity and avoid physical inactivity. STRONG
Level of evidence
Questions for research
Low
Effects of physical activity on physical function, recurrence and survival in cancer survivors
ESPEN GL Oncology
Section C5, Statement 2
C5 – 2
Cancer survivors: Healthy lifestyle
Strength of recommendation
In cancer survivors we recommend a healthy weight and a healthy (primarily plant based) diet, high in fruits, vegetables and whole grains, and low in fat, red meat and alcohol.
STRONG
Level of evidence
Questions for research
Low
Effects of healthy diet on outcome
ESPEN GL Oncology
Section C6, Statement 1
C6 – 1
Incurable patients: screening and assessment
Strength of recommendation
We recommend to routinely screen all advanced, incurable cancer patients ‐ whether receiving or not receiving anti‐
cancer treatment ‐ for inadequate nutritional intake, weight loss and low body mass index, and if found at risk, to assess
these patients further.
STRONG
Level of evidence
Questions for research
Low
Effects of malnutrition screening programs on quality of life in incurable
cancer patients
ESPEN GL Oncology
Section C6, Statement 2
C6 – 2
Incurable patients: ensuring nutritional intake
Strength of recommendation
Nutritional interventions should be used in patients with advanced incurtable cancer if their expected benefit outweighs the potential harm and the patient wants it.
STRONG
Level of evidence
Questions for research
Low
Effects of nutrtional care on quality of life in incurable cancer patients
ESPEN GL Oncology
Section C6, Statement 3
C6 – 3
Very advanced terminal phase
Strength of recommendation
In patients who are imminently dying treatment should be based on comfort. Artificial hydration and nutrition are unlikely to provide any benefit for most patients.
STRONG
Level of evidence
Low
Questions for research
ESPEN GL Oncology
espen ‐ epaac gl group
CA
AU
oncology anesthesiology physiology
radiooncology
hematology
surgery
surgery
dietitian
radiooncology
gastroenterology
nutrition
palliative medicine
nursing
pharmacology
internal medicine
health science
nutrition
Nutrition
oncology
palliative medicine
Arends
Bachmann
Baracos
Barthelemy
Bertz
Bozzetti
Fearon
Hütterer
Kaasa
Krznaric
Isenring
Laird
Larsson
Mühlebach
Muscaritol
Oldervoll
Ravasco
v.d. Schueren
Solheim
Strasser
ESPEN
Laviano
Preiser
(some experts have several affiliations)
ESPEN GL Oncology