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 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
288
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bavaria
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Erlangen, Bavaria, Tyskland, 91056
- Rekruttering
- Hector-Center for Nutrition, Exercise and Sports
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Kontakt:
- Prof. Dr. med. Yurdagül Zopf
- Telefonnummer: 0049091318545220
- E-mail: yurdaguel.zopf@uk-erlangen.de
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Placebo, no training
Placebo (corn oli) and no training program
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4x capsueles daily
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Placebo komparator: 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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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Skeletal Muscle Status I
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient-Reported Outcomes I
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Yurdagül Zopf, Prof. Dr. med., Universitätsklinikum Erlangen
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2026
Primær færdiggørelse (Anslået)
1. oktober 2028
Studieafslutning (Anslået)
1. oktober 2029
Datoer for studieregistrering
Først indsendt
14. januar 2026
Først indsendt, der opfyldte QC-kriterier
8. juni 2026
Først opslået (Faktiske)
11. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2026
Sidst verificeret
1. januar 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- Livskvalitet
- Træthed
- Eicosapentaensyre (EPA)
- Docosahexaensyre (DHA)
- Omega-3 fedtsyrer
- Træningsterapi
- Appetit
- Modstandstræning
- Kosttilskud
- Patientrapporterede resultater
- Fysisk præstation
- Understøttende kræftbehandling
- Ernæringsintervention
- Fiskeolietilskud
- Randomiseret placebokontrolleret forsøg
- Progressiv modstandsøvelse
- Protein-rich nutrition
- Cachexia risk
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SUPPORT-Study
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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