Hector-Center for Nutrition, Exercise and Sports
Erlangen, Bavaria, 91056, Germany
Location status: Recruiting
NCT Number: NCT07643558
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Erlangen, Bavaria, 91056, Germany
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4x capsules containing 500 mg EPA and 250 mg DHA
2x weekly resistance training
4x capsueles daily
Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Body composition: BIA (SMM in kg)
Time frame: 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)
Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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
Handgrip strength: dynamometer (in kg)
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Functional exercise capacity: 6-minute walk test (distance in m)
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Daily physical activity: International Physical Activity Questionnaire (IPAQ)
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Accelerometry over 7 consecutive days (steps)
Time frame: 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)]
Time frame: 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)
Time frame: 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)
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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
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
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
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
Edmonton Symptom Assessment Scale (ESAS) [0 (none) - 10 (worst possible)]
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Laboratory Endpoints: Omega-3 Fatty Acid Status as Blood-Based Biomarkers
University of Erlangen-Nürnberg Medical School
Other
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
Acronym: SUPPORT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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