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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
288
4x capsules containing 500 mg EPA and 250 mg DHA
2x weekly resistance training
4x capsueles daily
Hector-Center for Nutrition, Exercise and Sports
Erlangen, Bavaria, Germany
RECRUITINGSkeletal Muscle Status I
Body composition: BIA (SMM in kg)
Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Skeletal Muscle Status II
Muscle function: Tensiomyography (TMG) (Dm in mm, Tc in ms, Td in ms, Ts in ms, Tr in ms)
Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Skeletal Muscle Status III
Maximal muscle strength: estimated one-repetition maximum (1-RM in kg)
Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Skeletal Muscle Status IV
Handgrip strength: dynamometer (in kg)
Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Physical Performance I
Functional exercise capacity: 6-minute walk test (distance in m)
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Physical Performance II
Daily physical activity: International Physical Activity Questionnaire (IPAQ)
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Physical Performance III
Accelerometry over 7 consecutive days (steps)
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Nutritional Status I
Malnutrition screening: Nutritional Risk Screening Score (NRS 2002) \[0 (no risk) - 7 (highest risk)\]
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
Nutritional Status II
Dietary intake and nutrient analysis: 3 or 7-day dietary record for assessment of energy and protein intake (in g)
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
Nutritional Status III
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)
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
Patient-Reported Outcomes I
Appetite perception: VAS-scale (Visual Analog Scale 0 \[none\] - 10 \[excessive\])
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Patient-Reported Outcomes II
Quality of life: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Patient-Reported Outcomes III
Fatigue: The Functional Assessment of Chronic Illness Therapy (FACIT) - Scale \[0-52, higher scores indicate better quality of life and less severe fatigue\]
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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)
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Patient-Reported Outcomes IV
Edmonton Symptom Assessment Scale (ESAS) \[0 (none) - 10 (worst possible)\]
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Omega-3-Index
Laboratory Endpoints: Omega-3 Fatty Acid Status as Blood-Based Biomarkers
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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