Clinical trial Recruiting at 3 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment118 (estimated)
SponsorUniversity of Edinburgh
Academic / other
Locations4 sites (Oslo and 3 other locations)
StatusRecruiting
StartedApril 1, 2026
Main results expectedJanuary 2027
Study endsJune 2027
Registry record updatedOctober 20, 2026
Trial IDNCT07255066 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.