OPT-EPA is an international multi-centre randomised, open-label, two arm trial. Patients will be recruited from hospitals and cancer centres. Participants will be randomised to one of two arms in a 1:1 ratio. The first (experiemental) arm looks at providing dietary counselling and two servings of eicosapentaenoic acid (EPA) enriched oral nutritional supplements per day for 8 weeks and standard care. The second arm is dietary counselling and standard care using standard oral nutritional supplements if deemed clinically necessary. Participants will be screened to enter the study during Multidisciplinary Team Meetings to determine eligibility.

If a patient appears eligible, they will then be provided with the study information and allowed time to consider trial participation. If they are happy to take part, they will then provide signed informed consent. They will have all of the baseline investigations completed and go home for a week with an activity monitor (fitbit). 7 days later they will return to hospital to be randomised to one of the treatment arms, presuming their blood results confirm they are eligible. Once this is done they will then proceed to either have the experimental or the control arm. At day 21 they will have a dietary counselling phone call, at day 28 they will have a clinic visit in person where the same tests as baseline are completed. Day 42 will be another dietary counselling phone call/appointment and then finally there will be a clinic visit at day 56 where the same investigations are completed. At the day 56 visit, the participant will be given a wearable activity tracker which will need to be worn for 7 days and then posted back to the study team.  

Participants will be contacted approximately 7 days after they finish the intervention to check for any adverse events and remind them to return the activity monitor. Results from a standard of care scan completed within -2 weeks and + 2 months of the day 56 visit will be used to determine response to cancer therapy. The screening/baseline, randomisation, day 28 and day 56 visits will take approx. an hour and the day 21 and day 42 will take about 30 minutes. The participant will also be asked to complete Quality of Life Questionnaires (EQ-5D-5L) and EORTC QLQ-C30 at screening/baseline alongside the Patient Generated Subjective Global Assessment Short From (PG-SGA-SF). These will also be repeated at the 28 and 56 day vists. 

Participants with incurable cancer may face a number of barriers to recruitment, including physical and emotional fatigue, high symptom burden, limited mobility, and frequent medical appointments, which may reduce their ability or willingness to participate in research. Additionally, some may experience anxiety or uncertainty around trying new interventions or engaging in research at an advanced stage of illness. Socioeconomic factors, such as travel costs or lack of internet access, may also be barriers.

We will address these barriers by:

• Providing clear reassurance that the study does not replace or interfere with current clinical care.
• Clearly stating that participation is voluntary and can be withdrawn at any time without affecting care.
• Offering travel reimbursements where applicable.

Recruitment will take place via NHS oncology and palliative care services in both secondary and tertiary settings, ensuring a wide catchment area. To enhance diversity and inclusion, we will also:

• Collaborate with community palliative care teams and hospice services to engage individuals who may not be
• attending hospital regularly.
• Provide information about the study through cancer support charities and relevant patient organisations.
• Consider targeted outreach via social media, particularly platforms and groups that cater to cancer patients and carers.

We recognise the importance of clear, accessible communication and will ensure that all participant-facing materialsare designed accordingly:

• Participant Information Sheets (PIS) and Consent Forms will be written in lay language, avoiding technical jargon.
• Larger font versions of all materials will be available upon request.
• We will translate materials into other languages as needed, based on the demographics of recruitment sites.
• If required, we will arrange for interpreters (including BSL interpreters) during the consent process.
• Participants will be given ample time to read the information, ask questions, and discuss participation with family or carers before consenting.

There will be a variety of data which will be collected from participants, this includes;

• Demogrpahics (age, sex, ethnicity etc)
• Response to cancer therapy
• physical exam results (height and weight)
• Medication
• Vital Signs
• Questionnaire data
• Safety information (adverse events that you may experience)
• Activity tracking data via a fitbit

There will be data/material transfer between the data reported on the database and the Sponsor, safety data may also be sent to the funder, Danone.

Trial Status:

Open to recruitment

Population:

• Stage III-IV primary lung and/or colorectal cancer undergoing systemic treatment- Lung and colorectal cancer (excluding patients with recent history of tumour resection) 
   
• At nutritional risk (BMI <20 kg/m2 and/or weight loss between 5 and 10% in past 6 months) 
• Chronic low grade systemic inflammation (e.g., CRP>10 mg/dL)

Funder

The trial is funded by Danone Global Research & Innovation.