NCT07643558 Effects of Dietary Supplementation With omega3-fatty Acids (Fish Oil) and Progressive Resistance Training on Skeletal Muscle Status in Gynaecological, Gastrointestinal and Urological Cancer Patients
| NCT ID | NCT07643558 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Condition | Cancer Cachexia |
| Study Type | INTERVENTIONAL |
| Enrollment | 288 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 288 participants in total. It began in 2026-01-01 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Yurdagül Zopf, Prof. Dr. med.
STUDY CHAIR
Universitätsklinikum Erlangen
Frequently Asked Questions
Who can join the NCT07643558 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer Cachexia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07643558 currently recruiting?
Yes, NCT07643558 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Erlangen-Nürnberg Medical School to inquire about joining.
Where is the NCT07643558 trial being conducted?
This trial is being conducted at Erlangen, Germany.
Who is sponsoring the NCT07643558 clinical trial?
NCT07643558 is sponsored by University of Erlangen-Nürnberg Medical School. The principal investigator is Yurdagül Zopf, Prof. Dr. med. at Universitätsklinikum Erlangen. The trial plans to enroll 288 participants.
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