Optimizing Cancer Treatment with EPA-enriched Nutrition for Malnutrition
Official title: Optimizing Patient Treatment With EPA-enriched Nutrition, a Randomised Control Trial
Run by University of Edinburgh · NCT07255066 · Data updated 2026-11-12
This trial tests whether EPA-enriched nutrition helps undernourished adults with stage III–IV lung or colorectal cancer who are starting or receiving systemic cancer therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 118 (estimated) |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 4 sites (Oslo and 3 other locations) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | January 2027 |
| Study ends | June 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07255066 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with stage III–IV lung and/or colorectal cancer, at nutritional risk (BMI <20 kg/m2 or >5% weight loss in 6 months), with systemic inflammation, undergoing or starting systemic anti-cancer therapy, and able to consent.
✕Probably not a fit
Patients without malnutrition or those not meeting inflammatory and therapy criteria may not benefit from this nutrition intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, interventional trial investigates the role of EPA-enriched oral nutrition in malnourished adults with advanced lung or colorectal cancer who are undergoing or about to start systemic anti-cancer treatment. Participants must be at nutritional risk, have systemic inflammation, and meet other health criteria, then receive either an EPA-enriched nutrition product or standard care as part of cancer care. The study aims to see if this nutritional approach can improve weight, inflammatory status, and treatment tolerance. It is sponsored by the University of Edinburgh with collaboration from partner centers and industry, and it takes place at multiple European sites. Outcomes will inform whether EPA-enriched nutrition should be integrated into supportive care for malnourished cancer patients.
Why it matters
Potential benefit: If successful, participants could experience better nutritional status, improved tolerance to cancer therapy, and enhanced quality of life.
How similar studies have gone: Prior studies suggest omega-3–based nutrition can help inflammation and nutrition in cancer, but evidence for EPA-enriched products in this specific setting remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 over 5% weight loss in the previous 6 months\*\* * Participants with systemic inflammation within 28 days of screening (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 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
Where it's running
-
Edinburgh Cancer Centre
Edinburgh, United Kingdom Recruiting -
Gateshead NHS Trust
Gateshead, United Kingdom Recruiting -
Clatterbridge Cancer Centre
Liverpool, United Kingdom Recruiting -
Oslo University Hospital
Oslo, Norway Not yet recruiting
Study contacts
- Study coordinator: Jessica Kelly
- Email: opt-epa@soton.ac.uk
- Phone: +442380599247
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.