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

RecruitingNAAges 18 Years - anyAllUniversity of Edinburgh
NCT07255066 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 o

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📋 Eligibility rules (as published)
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
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What it tests

  • Fortimel Forticare Sensations
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Where

4 sites
Oslo University Hospital
Oslo, Norway
Edinburgh Cancer Centre
Edinburgh, United Kingdom
Gateshead NHS Trust
Gateshead, United Kingdom
Clatterbridge Cancer Centre
Liverpool, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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