About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Omega 3 FA (Fish Oil)
Dietary supplement4x capsules containing 500 mg EPA and 250 mg DHA
Training
Behavioral2x weekly resistance training
Corn Oil Placebo, 4 capsules/day for 12 weeks
Dietary supplement4x capsueles daily
Treatment groups
Trial outcomes
Primary outcomes
Skeletal Muscle Status I
Body composition: BIA (SMM in kg)
Skeletal Muscle Status II
Muscle function: Tensiomyography (TMG) (Dm in mm, Tc in ms, Td in ms, Ts in ms, Tr in ms)
Skeletal Muscle Status III
Maximal muscle strength: estimated one-repetition maximum (1-RM in kg)
Skeletal Muscle Status IV
Handgrip strength: dynamometer (in kg)
Secondary outcomes
Patient-Reported Outcomes I
Appetite perception: VAS-scale (Visual Analog Scale 0 \[none\] - 10 \[excessive\])
Patient-Reported Outcomes II
Quality of life: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
Patient-Reported Outcomes III
Fatigue: The Functional Assessment of Chronic Illness Therapy (FACIT) - Scale \[0-52, higher scores indicate better quality of life and less severe fatigue\]
Patient-Reported Outcomes III
Symptom burden and treatment-related side effects: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sponsors and contacts
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