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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo, no training | Placebo Comparator | Placebo (corn oli) and no training program |
|
| Placebo, training group | Placebo Comparator | Placebo (corn oli) and 2x weekly resistance training |
|
| Omega-3, no training | Experimental | Verum (Omega-3-capsules with fish oil) and no training program |
|
| Omega-3, training group | Experimental | Verum (Omega-3-capsules with fish oil) and 2x weekly resistance training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3 FA (Fish Oil) | Dietary Supplement | 4x capsules containing 500 mg EPA and 250 mg DHA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal Muscle Status I | Body composition: BIA (SMM in kg) | 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) | 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) | Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion |
| Skeletal Muscle Status IV | Handgrip strength: dynamometer (in kg) | 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) | baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion |
| Physical Performance II | Daily physical activity: International Physical Activity Questionnaire (IPAQ) | baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion |
| Physical Performance III | Accelerometry over 7 consecutive days (steps) | baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes I | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yurdagül Zopf, Prof. Dr. med. | Universitätsklinikum Erlangen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hector-Center for Nutrition, Exercise and Sports | Recruiting | Erlangen | Bavaria | 91056 | Germany |
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Randomized placebo-controlled trial
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| Training | Behavioral | 2x weekly resistance training |
|
| Corn Oil Placebo, 4 capsules/day for 12 weeks | Dietary Supplement | 4x capsueles daily |
|
| Nutritional Status I | 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 | 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 | 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) | baseline, 3 weeks, 6 weeks, 9 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 | 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 | 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 | Edmonton Symptom Assessment Scale (ESAS) [0 (none) - 10 (worst possible)] | 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 | baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009133 | Muscular Atrophy |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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