EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy -

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

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.

Study Overview

• Status: Unknown
• Conditions: Weight Loss; Abdominal Cancer; Radiotherapy; Complications; Protein Deficiency; Energy Supply
• Intervention / Treatment: Dietary supplement: Fish oil; Other: standard care

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 Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jens R Andersen, MD,MPA; Phone Number: +4523346654; Email: jra@nexs.ku.dk
• Study Contact Backup: Name: Poula Patursson, MSc, RD; Phone Number: +298 224 112; Email: poulapatursson@gmail.com

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Department of Oncology, Rigshospitalet
    • Contact: Jens R Andersen; Phone Number: +45 454523346654; Email: jra@nexs.ku.dk
    • Contact: Grith Møller; Phone Number: +45; Email: gmp@nexs.ku.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jens Rikardt Andersen
• Collaborators: Department of Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2018
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): February 1, 2021

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (ACTUAL): December 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Malnutrition; radiotherapy,; oral nutritional supplements; fish-oil
• Additional Relevant MeSH Terms: Nutrition Disorders; Body Weight; Deficiency Diseases; Malnutrition; Body Weight Changes; Weight Loss; Protein Deficiency
• Other Study ID Numbers: H-D-2007-0134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No