Optimering av patientbehandling med EPA-berikad nutrition, en randomiserad kontrollerad studie (OPT-EPA)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jessica Kelly
- Telefonnummer: +442380599247
- E-post: opt-epa@soton.ac.uk
Studera Kontakt Backup
- Namn: Conni McCarthy
- E-post: c.mccarthy@ed.ac.uk
Studieorter
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Oslo, Norge
- Har inte rekryterat ännu
- Oslo University Hospital
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Kontakt:
- Olav Olav
- Telefonnummer: +4722930000
- E-post: uxolaj@ous-hf.no
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-
-
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Edinburgh, Storbritannien
- Rekrytering
- Edinburgh Cancer Centre
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Kontakt:
- Iain Phillips
- Telefonnummer: 01315371052
- E-post: iain.phillips@nhs.scot
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Gateshead, Storbritannien
- Rekrytering
- Gateshead NHS Trust
-
Kontakt:
- Kerry Waterfield
- Telefonnummer: 01914455712
- E-post: kerry.waterfield@nhs.net
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Liverpool, Storbritannien
- Rekrytering
- Clatterbridge Cancer Centre
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Kontakt:
- Seamus Coyle
- E-post: seamus.coyle@nhs.net
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Dietistrådgivning och EPA-berikad FFS (experimentell ONS) och standardvård
|
An EPA-enriched experimental Oral Nutritional Supplement |
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Inget ingripande: Dietrådgivning och standardvård
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Kroppsvikt - lätt klädsel, inga skor
Tidsram: Från baslinje till dag 56
|
Från baslinje till dag 56
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Näringsstörningar
- Neoplasmer efter plats
- Neoplasmer
- Tarmsjukdomar
- Luftvägssjukdomar
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Lungsjukdomar
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Kolonsjukdomar
- Närings- och metabola sjukdomar
- Undernäring
- Lungneoplasmer
- Kolorektala neoplasmer
Andra studie-ID-nummer
- AC25085
- 2024-07601 (Annat bidrag/finansieringsnummer: Danone Global Research and Innovation)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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