EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy -

NCT04687124 | Unknown Phase 4

• 1 other identifier: H-D-2007-0134
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Malnutrition; radiotherapy,; oral nutritional supplements; fish-oil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• energy intake (kJ/day) in % of estimated needs

  6 weeks

• protein intake (g/kg body weight/day) in % of estimated needs

  6 weeks

• Quality of life score (EORTC QLQ-C30 version 3.0) points

  6 weeks

• treatment-related side-effects (VAS) scale

  6 weeks

Study Arms (2)

Fish oil

ACTIVE COMPARATOR

dietary counselling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)

Dietary Supplement: Fish oil

standard care

PLACEBO COMPARATOR

The departmental usual procedure with the possibility of requiring of a dietician when needed

Other: standard care

Interventions

Fish oil DIETARY_SUPPLEMENT

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

Also known as: Dietary counseling

Fish oil

standard care OTHER

No specified intervention

standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• conditions precluding evaluations of end-points
• dementia
• operations planned in the observation period

Sponsors & Collaborators

• Jens Rikardt Andersen: lead
• Department of Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen: collaborator

Study Sites (1)

Department of Oncology, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 34024504 DERIVED

MeSH Terms

Conditions

Weight Loss; Protein Deficiency; Malnutrition

Interventions

Fish Oils; Nutrition Assessment; Standard of Care

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Deficiency Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Quality Indicators, Health Care; Health Services Administration

Central Study Contacts

Jens R Andersen, MD,MPA

CONTACT

+4523346654; jra@nexs.ku.dk

Poula Patursson, MSc, RD

CONTACT

+298 224 112; poulapatursson@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor - Investigator

Model Details: Randomization by sealed envelopes. Stratified for location of cancer

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 29, 2020
• Study Start: February 15, 2018
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)