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 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Studientyp
Interventionell
Einschreibung (Geschätzt)
288
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Bavaria
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Erlangen, Bavaria, Deutschland, 91056
- Rekrutierung
- 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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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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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Experimental: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Skeletal Muscle Status I
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Patient-Reported Outcomes I
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Studienstuhl: Yurdagül Zopf, Prof. Dr. med., Universitätsklinikum Erlangen
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Januar 2026
Primärer Abschluss (Geschätzt)
1. Oktober 2028
Studienabschluss (Geschätzt)
1. Oktober 2029
Studienanmeldedaten
Zuerst eingereicht
14. Januar 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Juni 2026
Zuerst gepostet (Tatsächlich)
11. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Juni 2026
Zuletzt verifiziert
1. Januar 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- Lebensqualität
- Ermüdung
- Eicosapentaensäure (EPA)
- Docosahexaensäure (DHA)
- Omega-3-Fettsäuren
- Bewegungstherapie
- Appetit
- Krafttraining
- Nahrungsergänzung
- Von Patienten berichtete Ergebnisse
- Körperliche Leistung
- Unterstützende Krebsbehandlung
- Ernährungsintervention
- Nahrungsergänzung mit Fischöl
- Randomisierte, placebokontrollierte Studie
- Progressive Widerstandsübung
- Protein-rich nutrition
- Cachexia risk
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SUPPORT-Study
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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