EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy -

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04687124
• Other study ID #: H-D-2007-0134
• Status: Recruiting
• Phase: Phase 4
• Start date: February 15, 2018
• Est. completion date: February 2021

Study information

• Verified date: December 2020
• Source: University of Copenhagen
• Contact: Jens R Andersen, MD,MPA
• Phone: +4523346654
• Email: jra[@]nexs.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: February 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Cancer
• Energy Supply
• Protein Deficiency
• Radiotherapy; Complications
• Weight Loss

Intervention

Dietary Supplement:
• Fish oil
Dietary counseling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)

Other:
• standard care
No specified intervention

Locations

Country	Name	City	State
Denmark	Department of Oncology, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Jens Rikardt Andersen	Department of Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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