Malnutrition (Calorie)OPT-EPANCT07255066
Optimizing Patient Treatment With EPA-enriched Nutrition, a Randomised Control Trial
A study testing Fortimel Forticare Sensations in people with Malnutrition (Calorie) and Colorectal Cancer, run by University of Edinburgh at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition (Calorie), Colorectal Cancer, Lung Cancer
- What is being tested?
- Fortimel Forticare Sensations
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Apr 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Conni McCarthy contact
4 sites in 2 countries
United Kingdom3 sites, 3 recruiting
- Recruiting
Edinburgh Cancer Centre
Edinburgh
Iain Phillips, 01315371052, iain.phillips@nhs.scot
- Recruiting
Gateshead NHS Trust
Gateshead
Kerry Waterfield, 01914455712, kerry.waterfield@nhs.net
- Recruiting
Clatterbridge Cancer Centre
Liverpool
Seamus Coyle, seamus.coyle@nhs.net
Norway1 site, 1 recruiting
- Not yet recruiting
Oslo University Hospital
Oslo
Olav Olav, +4722930000, uxolaj@ous-hf.no
About this study
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.
Read more
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.
- Conditions
- Malnutrition (Calorie), Colorectal Cancer, Lung Cancer
- Being tested
- Fortimel Forticare Sensations
- Medical subject headings
- Malnutrition, Colorectal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortimel Forticare SensationsDietary supplement
An EPA-enriched experimental Oral Nutritional Supplement
| Study group | Role | What they receive |
|---|---|---|
| Dietary Counselling and EPA-enriched FFS (experimental ONS) and standard care | Experimental | Not described Receives: Dietary Supplement: Fortimel Forticare Sensations |
| Dietary Counselling and standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight - light clothes, no shoes
Measured: From baseline to day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Apr 2026
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition (Calorie)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton, Danone Global Research & Innovation Center, Edinburgh and Lothain Health Fund (Lothian Health Board)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255066
- Sponsor's protocol ID
- AC25085
- Other IDs
- 2024-07601
- Acronym
- OPT-EPA
- Status last verified
- May 2026
- First submitted
- 19 Nov 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Patient Treatment With EPA-enriched Nutrition, a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT07255066
- Acronym / sponsor ID
- OPT-EPA / AC25085
- Conditions
- Malnutrition (Calorie), Colorectal Cancer, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- University of Southampton, Danone Global Research & Innovation Center, Edinburgh and Lothain Health Fund (Lothian Health Board)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Counselling and EPA-enriched FFS (experimental ONS) and standard care | Experimental | Dietary Supplement: Fortimel Forticare Sensations |
| Dietary Counselling and standard care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fortimel Forticare SensationsAn EPA-enriched experimental Oral Nutritional Supplement | Dietary supplement | Dietary Counselling and EPA-enriched FFS (experimental ONS) and standard care |
Primary outcome
Body Weight - light clothes, no shoes
Time frame: From baseline to day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Conni McCarthy contact
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortimel Forticare Sensations in people with Malnutrition (Calorie) and Colorectal Cancer, run by University of Edinburgh at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Kelly (+442380599247, opt-epa@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight - light clothes, no shoes (time frame: From baseline to day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.