EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy -

Study Overview
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Brief Summary
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Malnutrition occurs frequently in patients with cancer during and after radiotherapy to the gastrointestinal (GI) area and can lead to negative outcomes. N-3 fatty acids from fish, especially eicosapentaenoic acid (EPA) may possess anticachectic properties. The aim of this study is to investigate the effect of two nutritional interventions; dietary counselling and an oral nutritional supplement (ONS) containing 2.2 g of the n-3 fatty acid EPA (Forticare®) or standard care, including dietary counselling and protein supplementation when needed.

Detailed Description
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Methods: Outpatients commencing radiotherapy to the GI area due to dissiminated cancer are randomized to receive dietary counselling and daily fish-oil supplementation over a 5-7 week period, or standard care. Outcome parameters are measured at baseline (onset of radiotherapy), week 5, and 12 weeks after commencing radiotherapy, with one additional measurement of body weight at week 2. Quality of life (QoL) is measured using the EORTC QLQ-C30 questionnaire. Radiotherapy-related side effects are assessed using a questionnaire developed specifically for this study. Data from a historical control group collected in a previous observational study is included in this study to compare incidence of weight loss.

Official Title
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N-3 Fatty Acid EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy - A Randomised Controlled Trial.

Conditions
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Abdominal Cancer, Radiotherapy; Complications, Weight Loss, Energy Supply, Protein Deficiency

Intervention / Treatment
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* Dietary Supplement: Fish oil
* Other: standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: referred to radiotherapy for dissminated, abdominal cancer > 18 years of age able to understand and comply with the intervention willingness to participate after oral and written conscent Exclusion Criteria: conditions precluding evaluations of end-points dementia operations planned in the observation period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization by sealed envelopes. Stratified for location of cancer
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fish oil<br>dietary counselling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®) | Dietary Supplement: Fish oil<br>* Dietary counseling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)<br>* Other names: Dietary counseling;|
| Placebo Comparator: standard care<br>The departmental usual procedure with the possibility of requiring of a dietician when needed | Other: standard care<br>* No specified intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight (%) | accumulated weight-loss or gain in per cent of the weight measured between baseline, end of treatment and at follow-up | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| energy intake (kJ/day) in % of estimated needs | Mean of 3 meausrements in the obeservation period | 6 weeks | 
| protein intake (g/kg body weight/day) in % of estimated needs | Mean of 3 meausrements in the obeservation period | 6 weeks | 
| Quality of life score (EORTC QLQ-C30 version 3.0) points | difference - before and after intervention | 6 weeks | 
| treatment-related side-effects (VAS) scale | questionaire before and after intervention | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, radiotherapy,, oral nutritional supplements, fish-oil