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

University of Edinburgh

Status

Begins enrollment this month

Conditions

Lung Cancer

Malnutrition (Calorie)

Colorectal Cancer

Treatments

Dietary Supplement: Fortimel Forticare Sensations

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07255066

AC25085

2024-07601 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

118 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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