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

Study acronym: OPT-EPA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Trial sites expanded: 0 → 4 locations · Start date changed from estimate of Jun 2026 to Apr 1, 2026 · Eligibility criteria shortened, about 11 words · 1 more Show 4 more changesShow less
    • Trial sites expanded: 0 → 4 locations
    • Start date changed from estimate of Jun 2026 to Apr 1, 2026
    • Eligibility criteria shortened, about 11 words
    • Collaborators: 2 to 3
  2. Notable Start date: Mar 2026 to Jun 2026v5
  3. Notable Start date: Dec 2025 to Mar 2026v4
  4. Notable Phase: Phase 3 to Not applicablev3
  5. Minor Start date: Nov 2025 to Dec 2025v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07255066
Lead Sponsor University of Edinburgh
Collaborators: University of Southampton, Danone Global Research & Innovation Center, Edinburgh and Lothain Health Fund (Lothian Health Board)
Conditions Malnutrition (Calorie), Colorectal Cancer, Lung Cancer
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov