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 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
288
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bavaria
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Erlangen, Bavaria, Alemania, 91056
- Reclutamiento
- Hector-Center for Nutrition, Exercise and Sports
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Contacto:
- Prof. Dr. med. Yurdagül Zopf
- Número de teléfono: 0049091318545220
- Correo electrónico: yurdaguel.zopf@uk-erlangen.de
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Placebo, no training
Placebo (corn oli) and no training program
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4x capsueles daily
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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Skeletal Muscle Status I
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient-Reported Outcomes I
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Yurdagül Zopf, Prof. Dr. med., Universitätsklinikum Erlangen
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2026
Finalización primaria (Estimado)
1 de octubre de 2028
Finalización del estudio (Estimado)
1 de octubre de 2029
Fechas de registro del estudio
Enviado por primera vez
14 de enero de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de junio de 2026
Publicado por primera vez (Actual)
11 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de junio de 2026
Última verificación
1 de enero de 2026
Más información
Términos relacionados con este estudio
Palabras clave
- Calidad de vida
- Fatiga
- Ácido eicosapentaenoico (EPA)
- Ácido docosahexaenoico (DHA)
- Ácidos grasos omega-3
- Terapia de ejercicio
- Apetito
- Entrenamiento de resistencia
- Suplementación nutricional
- Resultados informados por el paciente
- Desempeño físico
- Atención oncológica de apoyo
- Intervención nutricional
- Suplementos de aceite de pescado
- Ensayo aleatorizado controlado con placebo
- Ejercicio de resistencia progresiva
- Protein-rich nutrition
- Cachexia risk
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SUPPORT-Study
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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