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| Name | Class |
|---|---|
| Department of Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish oil | Active Comparator | dietary counselling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®) |
|
| standard care | Placebo Comparator | The departmental usual procedure with the possibility of requiring of a dietician when needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish oil | Dietary Supplement | Dietary counseling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens R Andersen, MD,MPA | Contact | +4523346654 | jra@nexs.ku.dk | |
| Poula Patursson, MSc, RD | Contact | +298 224 112 | poulapatursson@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34024504 | Derived | Patursson P, Moller G, Muhic A, Andersen JR. N-3 fatty acid EPA supplementation in cancer patients receiving abdominal radiotherapy - A randomised controlled trial. Clin Nutr ESPEN. 2021 Jun;43:130-136. doi: 10.1016/j.clnesp.2021.03.001. Epub 2021 Mar 16. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D011488 | Protein Deficiency |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| D015596 | Nutrition Assessment |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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Randomization by sealed envelopes. Stratified for location of cancer
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| standard care | Other | No specified intervention |
|
| 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 |
| D003677 | Deficiency Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D008919 |
| Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D019984 | Quality Indicators, Health Care |
| D006298 | Health Services Administration |