EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy -

Phase 4

• Conditions: Radiotherapy; Complications; Protein Deficiency; Abdominal Cancer; Weight Loss; Energy Supply
• Interventions: Dietary Supplement: Fish oil; Other: standard care

• Registration Number: NCT04687124
• Lead Sponsor: Jens Rikardt Andersen

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.

Study Timeline

• Study Start: 2018-02-15
• Status Verified: 2020-12
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-23
• Last Update Submitted: 2020-12-23
• Study First Posted: 2020-12-29
• Last Update Posted: 2020-12-29
• Primary Completion: 2021-01
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish oil	Fish oil	dietary counselling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)
standard care	standard care	The departmental usual procedure with the possibility of requiring of a dietician when needed

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Oncology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark