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

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка Omega 3 FA (Fish Oil)
  4x capsules containing 500 mg EPA and 250 mg DHA
• Поведенческое Training
  2x weekly resistance training
• Пищевая добавка Corn Oil Placebo, 4 capsules/day for 12 weeks
  4x capsueles daily

Первичные конечные точки

• Skeletal Muscle Status I [Срок оценки: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Skeletal Muscle Status II [Срок оценки: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Skeletal Muscle Status III [Срок оценки: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Skeletal Muscle Status IV [Срок оценки: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Physical Performance I [Срок оценки: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Physical Performance II [Срок оценки: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Physical Performance III [Срок оценки: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Nutritional Status I [Срок оценки: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion]
• Nutritional Status II [Срок оценки: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion]
• Nutritional Status III [Срок оценки: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion]

Вторичные конечные точки (6)

• Patient-Reported Outcomes I [Срок оценки: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Patient-Reported Outcomes II [Срок оценки: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Patient-Reported Outcomes III [Срок оценки: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Patient-Reported Outcomes III [Срок оценки: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Patient-Reported Outcomes IV [Срок оценки: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Omega-3-Index [Срок оценки: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Германия · 1 центр

• Hector-Center for Nutrition, Exercise and Sports — Erlangen

Идентификаторы

NCT: NCT07643558 · SUPPORT-Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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