Clinical trial NCT04687124: EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy -
Official title: N-3 Fatty Acid EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy - A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Abdominal Cancer
Radiotherapy; Complications
Weight Loss
Energy Supply
Protein Deficiency
Keywords: Malnutrition
radiotherapy,
oral nutritional supplements
fish-oil
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Department of Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
First posted: 2020-12-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization by sealed envelopes. Stratified for location of cancer
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in weight (%)
timeFrame: 6 weeks
Secondary outcomes:
measure: energy intake (kJ/day) in % of estimated needs
timeFrame: 6 weeks
measure: protein intake (g/kg body weight/day) in % of estimated needs
timeFrame: 6 weeks
measure: Quality of life score (EORTC QLQ-C30 version 3.0) points
timeFrame: 6 weeks
measure: treatment-related side-effects (VAS) scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Oncology, Rigshospitalet
Study officials:
References:
citation: 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.