Effects of Dietary Supplementation With omega3-fatty Acids (Fish Oil) and Progressive Resistance Training on Skeletal Muscle Status in Gynaecological, Gastrointestinal and Urological Cancer Patients (SUPPORT)
8 juni 2026 bijgewerkt door: University of Erlangen-Nürnberg Medical School
SUPPORT-Study = Effects of a Dietary SUPPlementation With Omega3-fatty Acids/ Fish Oil and Progressive Resistence Training on Skeletal Muscle Status in Gynaecological, Gastrointestinal, and Urological Cancer Patients
Cancer cachexia is a common and prognostically relevant complication of advanced malignancies, characterized by systemic inflammation, increased catabolism, and reduced nutritional intake, leading to a progressive loss of skeletal muscle mass, physical performance, and quality of life. Muscle wasting negatively affects the tolerability and efficacy of oncological therapies and exacerbates distressing symptoms such as fatigue. Consequently, international guidelines recommend combined nutritional and exercise interventions as key components of supportive cancer care. However, due to treatment-related limitations, conventional exercise programs are often difficult to implement, highlighting the need for feasible, time-efficient, and individually adaptable training concepts suitable for daily life.
In addition, adequate protein-rich nutrition is essential and may be supported by targeted nutritional supplementation. Omega-3 fatty acids, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have demonstrated anti-inflammatory effects and beneficial influences on nutritional status, quality of life, and potentially skeletal muscle mass.
The aim of the present project is to investigate, in a randomized, placebo-controlled trial, whether the combination of progressive resistance training (twice-weekly TheraBand-based exercise) and omega-3 supplementation (daily intake of 2 g EPA and 1 g DHA administered as fish oil capsules) can improve muscle status, physical performance, and patient-relevant outcomes such as quality of life, appetite, and fatigue in cancer patients at high risk of developing cancer cachexia.
Studie Overzicht
Toestand
Werving
Studietype
Ingrijpend
Inschrijving (Geschat)
288
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Bavaria
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Erlangen, Bavaria, Duitsland, 91056
- Werving
- Hector-Center for Nutrition, Exercise and Sports
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Contact:
- Prof. Dr. med. Yurdagül Zopf
- Telefoonnummer: 0049091318545220
- E-mail: yurdaguel.zopf@uk-erlangen.de
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Patients with malignant tumors undergoing curative or palliative treatment, including breast, ovarian, esophageal, pancreatic, gastric, colon, rectal, and prostate cancer, across all UICC stages
- Women and men aged 18 years or older
- ECOG performance status 0-2
Exclusion Criteria:
- Patients younger than 18 years
- Bone metastases or skeletal involvement associated with a high risk of fracture
- Pregnant or breastfeeding women
- Patients with psychiatric disorders that raise concerns regarding decision-making capacity or ability to provide informed consent
- Participation in other exercise and/or nutritional intervention studies within the previous 3 months
- Current use of fish oil supplements
- Severe cardiovascular disease, NYHA class IV
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Placebo-vergelijker: Placebo, no training
Placebo (corn oli) and no training program
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4x capsueles daily
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Placebo-vergelijker: Placebo, training group
Placebo (corn oli) and 2x weekly resistance training
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4x capsueles daily
2x weekly resistance training
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Experimenteel: Omega-3, no training
Verum (Omega-3-capsules with fish oil) and no training program
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4x capsules containing 500 mg EPA and 250 mg DHA
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Experimenteel: Omega-3, training group
Verum (Omega-3-capsules with fish oil) and 2x weekly resistance training
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2x weekly resistance training
4x capsules containing 500 mg EPA and 250 mg DHA
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Skeletal Muscle Status I
Tijdsspanne: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Body composition: BIA (SMM in kg)
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Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Skeletal Muscle Status II
Tijdsspanne: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Muscle function: Tensiomyography (TMG) (Dm in mm, Tc in ms, Td in ms, Ts in ms, Tr in ms)
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Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Skeletal Muscle Status III
Tijdsspanne: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Maximal muscle strength: estimated one-repetition maximum (1-RM in kg)
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Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Skeletal Muscle Status IV
Tijdsspanne: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Handgrip strength: dynamometer (in kg)
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Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Physical Performance I
Tijdsspanne: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Functional exercise capacity: 6-minute walk test (distance in m)
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Physical Performance II
Tijdsspanne: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Daily physical activity: International Physical Activity Questionnaire (IPAQ)
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Physical Performance III
Tijdsspanne: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Accelerometry over 7 consecutive days (steps)
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Nutritional Status I
Tijdsspanne: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
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Malnutrition screening: Nutritional Risk Screening Score (NRS 2002) [0 (no risk) - 7 (highest risk)]
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baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
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Nutritional Status II
Tijdsspanne: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
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Dietary intake and nutrient analysis: 3 or 7-day dietary record for assessment of energy and protein intake (in g)
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baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
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Nutritional Status III
Tijdsspanne: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
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Dietary intake and nutrient analysis: 3 or 7-day dietary record and assessment of consumption of EPA- and DHA-rich foods, and omega-3/omega-6 fatty acid ratio (in g)
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baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Patient-Reported Outcomes I
Tijdsspanne: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Appetite perception: VAS-scale (Visual Analog Scale 0 [none] - 10 [excessive])
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Patient-Reported Outcomes II
Tijdsspanne: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Quality of life: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Patient-Reported Outcomes III
Tijdsspanne: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Fatigue: The Functional Assessment of Chronic Illness Therapy (FACIT) - Scale [0-52, higher scores indicate better quality of life and less severe fatigue]
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Patient-Reported Outcomes III
Tijdsspanne: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Symptom burden and treatment-related side effects: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Patient-Reported Outcomes IV
Tijdsspanne: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Edmonton Symptom Assessment Scale (ESAS) [0 (none) - 10 (worst possible)]
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Omega-3-Index
Tijdsspanne: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Laboratory Endpoints: Omega-3 Fatty Acid Status as Blood-Based Biomarkers
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie stoel: Yurdagül Zopf, Prof. Dr. med., Universitätsklinikum Erlangen
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2026
Primaire voltooiing (Geschat)
1 oktober 2028
Studie voltooiing (Geschat)
1 oktober 2029
Studieregistratiedata
Eerst ingediend
14 januari 2026
Eerst ingediend dat voldeed aan de QC-criteria
8 juni 2026
Eerst geplaatst (Werkelijk)
11 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
8 juni 2026
Laatst geverifieerd
1 januari 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- Kwaliteit van het leven
- Vermoeidheid
- Eicosapentaeenzuur (EPA)
- Docosahexaeenzuur (DHA)
- Omega-3 vetzuren
- Oefentherapie
- Trek
- Weerstandstraining
- Voedingssupplementen
- Patiëntgerapporteerde resultaten
- Fysieke prestatie
- Ondersteunende kankerzorg
- Voedingsinterventie
- Suppletie van visolie
- Gerandomiseerde placebogecontroleerde studie
- Progressieve weerstandsoefening
- Protein-rich nutrition
- Cachexia risk
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SUPPORT-Study
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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