Optimizing Patient Treatment With EPA-enriched Nutrition, a Randomised Control Trial (OPT-EPA)

Malnutrition is a common and serious issue for people living with cancer. Many cancer patients experience weight loss, muscle weakness, and poor quality of life due to malnutrition. This can also reduce the success of cancer treatments, increase hospital visits, and add emotional distress for both patients and their loved ones.

Treating malnutrition through good nutritional care is increasingly recognised as an important part of cancer treatment. Leading experts recommend that all cancer patients be checked for signs of malnutrition and given personalised nutrition plans when necessary. While dietary counselling and oral nutritional supplements (ONS) are often used to help patients, there is still a need for better evidence to show how well these interventions work.

A key factor contributing to malnutrition in cancer patients is inflammation. Omega-3 fatty acids, (like those found in oily fish) are known for their anti-inflammatory properties. Some studies suggest that omega-3s may help cancer patients by reducing inflammation, keeping muscles strong, improving appetite, and enhancing overall well-being.

The OPT-EPA study will investigate whether a nutritional drink, called Fortimel Forticare Sensations (FFS), can improve nutritional status in patients with lung or colorectal cancer who are at risk of malnutrition. This drink is enriched with omega-3 fatty acids (Eicosapentanoic acid (EPA) and Docosahexaenoic acid (DHA)) and provides a high amount of protein and calories in a small volume, making it easier to consume, especially for patients with taste changes.

In this study, participants will be divided into two groups. The experimental group will receive dietary counselling and standard care along with FFS, the omega-3-enriched nutritional drink, while the other (control) group will receive dietary counselling and standard care, with supplements provided only if clinically necessary. Researchers will evaluate the impact on patients' nutritional status, body weight, muscle, inflammation levels, and quality of life.

Through the OPT-EPA study, researchers hope to gain clearer insights into whether omega-3-containing supplements can provide meaningful benefits for cancer patients. Ultimately, this could help improve the quality of care and outcomes for people facing cancer-related malnutrition.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Lung Cancer; Malnutrition (Calorie)
• Intervention / Treatment: Dietary supplement: Fortimel Forticare Sensations

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with stage III-IV lung and/or colorectal cancer undergoing systemic anti-cancer treatment (SACT) or starting SACT within the next 4 weeks *with non-curative intent
• Participants aged 18 or older
• Participants at nutritional risk defined as a BMI <20 kg/m2 and/or weight loss between 5-10% in the previous 6 months**
• Participants with systemic inflammation within 28 days of screening (e.g. CRP >10 mg/dL)
• Participants with an ECOG-PS*** score of 0, 1 or 2
• Participants willing and able to give written informed consent

Exclusion Criteria:

• Participants with a recent history of tumour resection (within 12 months)
• Participants who have lost >10% body weight in the previous 6 months before baseline - observed or participant reported.
• Participants with severe renal or hepatic failure or an intolerance to any of the ingredients of the study product
• Participants who are using dietary counselling, ONS or any form of artificial feeding at the time of recruitment
• Unable to adhere to either arm of the trial and appropriate requirements
• Contraindication to ONS including a lactose intolerance
• Females who are pregnant or of childbearing potential and not using adequate contraception

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary Counselling and EPA-enriched FFS (experimental ONS) and standard care	Dietary supplement: Fortimel Forticare Sensations; An EPA-enriched experimental Oral Nutritional Supplement
No Intervention: Dietary Counselling and standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body Weight - light clothes, no shoes	From baseline to day 56

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: University of Southampton; Danone Global Research & Innovation Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Neoplasms by Site; Neoplasms; Intestinal Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Nutritional and Metabolic Diseases; Malnutrition; Lung Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: AC25085; 2024-07601 (Other Grant/Funding Number: Danone Global Research and Innovation)

Drug and device information, study documents

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