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 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
288
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Bavaria
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Erlangen, Bavaria, Allemagne, 91056
- Recrutement
- Hector-Center for Nutrition, Exercise and Sports
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Contact:
- Prof. Dr. med. Yurdagül Zopf
- Numéro de téléphone: 0049091318545220
- E-mail: yurdaguel.zopf@uk-erlangen.de
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Placebo, no training
Placebo (corn oli) and no training program
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4x capsueles daily
|
|
Comparateur placebo: 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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Expérimental: 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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|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Skeletal Muscle Status I
Délai: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Body composition: BIA (SMM in kg)
|
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Skeletal Muscle Status II
Délai: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Muscle function: Tensiomyography (TMG) (Dm in mm, Tc in ms, Td in ms, Ts in ms, Tr in ms)
|
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Skeletal Muscle Status III
Délai: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Maximal muscle strength: estimated one-repetition maximum (1-RM in kg)
|
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Skeletal Muscle Status IV
Délai: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Handgrip strength: dynamometer (in kg)
|
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Physical Performance I
Délai: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Functional exercise capacity: 6-minute walk test (distance in m)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Physical Performance II
Délai: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Daily physical activity: International Physical Activity Questionnaire (IPAQ)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Physical Performance III
Délai: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Accelerometry over 7 consecutive days (steps)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Nutritional Status I
Délai: 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)]
|
baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Nutritional Status II
Délai: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
Dietary intake and nutrient analysis: 3 or 7-day dietary record for assessment of energy and protein intake (in g)
|
baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Nutritional Status III
Délai: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient-Reported Outcomes I
Délai: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Appetite perception: VAS-scale (Visual Analog Scale 0 [none] - 10 [excessive])
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Patient-Reported Outcomes II
Délai: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Quality of life: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Patient-Reported Outcomes III
Délai: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Fatigue: The Functional Assessment of Chronic Illness Therapy (FACIT) - Scale [0-52, higher scores indicate better quality of life and less severe fatigue]
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Patient-Reported Outcomes III
Délai: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Symptom burden and treatment-related side effects: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Patient-Reported Outcomes IV
Délai: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
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
|
|
Omega-3-Index
Délai: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chaise d'étude: Yurdagül Zopf, Prof. Dr. med., Universitätsklinikum Erlangen
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2026
Achèvement primaire (Estimé)
1 octobre 2028
Achèvement de l'étude (Estimé)
1 octobre 2029
Dates d'inscription aux études
Première soumission
14 janvier 2026
Première soumission répondant aux critères de contrôle qualité
8 juin 2026
Première publication (Réel)
11 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 juin 2026
Dernière vérification
1 janvier 2026
Plus d'information
Termes liés à cette étude
Mots clés
- Qualité de vie
- Fatigue
- Acide eicosapentaénoïque (EPA)
- Acide docosahexaénoïque (DHA)
- Les acides gras omega-3
- Thérapie par l'exercice
- Appétit
- Entraînement en résistance
- Supplémentation nutritionnelle
- Résultats rapportés par les patients
- Performance physique
- Soins de soutien contre le cancer
- Intervention nutritionnelle
- Supplémentation en huile de poisson
- Essai randomisé contrôlé par placebo
- Exercice de résistance progressive
- Protein-rich nutrition
- Cachexia risk
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SUPPORT-Study
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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