Cancer, Cancer Cachexia, Muscle Wasting, Omega 3, Resistance Training, Systemic Inflammation
Conditions
Keywords
Resistance training, Progressive resistance exercise, Exercise therapy, Supportive cancer care, Nutritional intervention, Protein-rich nutrition, Nutritional supplementation, Omega-3 fatty acids, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA), Fish oil supplementation, Physical performance, Quality of life, Fatigue, Appetite, Patient-reported outcomes, Randomized placebo-controlled trial, Cachexia risk
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTOmega 3 FA (Fish Oil)
4x capsules containing 500 mg EPA and 250 mg DHA
BEHAVIORALTraining
2x weekly resistance training
DIETARY_SUPPLEMENTCorn Oil Placebo, 4 capsules/day for 12 weeks
4x capsueles daily
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal Muscle Status I | Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion | Body composition: BIA (SMM in kg) |
| Skeletal Muscle Status II | Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion | Muscle function: Tensiomyography (TMG) (Dm in mm, Tc in ms, Td in ms, Ts in ms, Tr in ms) |
| Skeletal Muscle Status III | Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion | Maximal muscle strength: estimated one-repetition maximum (1-RM in kg) |
| Skeletal Muscle Status IV | Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion | Handgrip strength: dynamometer (in kg) |
| Physical Performance I | baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion | Functional exercise capacity: 6-minute walk test (distance in m) |
| Physical Performance II | baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion | Daily physical activity: International Physical Activity Questionnaire (IPAQ) |
| Physical Performance III | baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion | Accelerometry over 7 consecutive days (steps) |
| Nutritional Status I | baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion | Malnutrition screening: Nutritional Risk Screening Score (NRS 2002) \[0 (no risk) - 7 (highest risk)\] |
| Nutritional Status II | baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion | Dietary intake and nutrient analysis: 3 or 7-day dietary record for assessment of energy and protein intake (in g) |
| Nutritional Status III | baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes I | baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion | Appetite perception: VAS-scale (Visual Analog Scale 0 \[none\] - 10 \[excessive\]) |
| Patient-Reported Outcomes II | baseline, 6 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) |
| Patient-Reported Outcomes III | baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion | 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 IV | baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion | Edmonton Symptom Assessment Scale (ESAS) \[0 (none) - 10 (worst possible)\] |
| Omega-3-Index | baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion | Laboratory Endpoints: Omega-3 Fatty Acid Status as Blood-Based Biomarkers |
Countries
Germany
Contacts
STUDY_CHAIRYurdagül Zopf, Prof. Dr. med.
Universitätsklinikum Erlangen
Outcome results
None listed