Exploring exercise and molecular factors in cancer-related muscle loss
Identifying Molecular Factors Contributing to Cancer-associated Muscle Mass Loss and Providing Clinical Evidence for Exercise Mechanisms to Functionally Restore Muscle in Cancer
This study tests whether exercise can help people with non-small cell lung cancer who are losing muscle mass feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (Copenhagen, DK) |
| Trial ID | NCT05307367 on ClinicalTrials.gov |
What this trial studies
This study investigates the loss of muscle mass associated with cancer, particularly focusing on cancer cachexia, which affects a significant number of patients with metastatic cancer. It aims to understand the molecular factors contributing to this condition and the role of exercise in mitigating muscle loss. Participants will engage in exercise training as part of the intervention, with the goal of improving physical function and quality of life. The study will include patients with non-small cell lung cancer who are not eligible for concurrent chemotherapy or radiation therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed non-small cell lung cancer at stage IIIb/IV who are referred for palliative anticancer therapy.
Not a fit: Patients with other active malignancies requiring treatment or those receiving local palliative radiotherapy as primary treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective strategies for preventing muscle mass loss in cancer patients, improving their quality of life and treatment outcomes.
How similar studies have performed: While the approach of combining exercise with cancer treatment is gaining attention, the specific focus on molecular factors in cancer cachexia is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria, WP1+WP2X+WP2: * Men and women at or above the age of 18 * Histological and radiological verified NSCLC (both squamous and adenocarcinoma) st. IIIb/IV stage not eligible to concurrent chemo/radiation therapy as primary treatment * Referred for 1st line palliative anticancer therapy (platin based, immunotherapy, combined therapy or TKI), this goes for WP1 + WP2 * Referred for palliative anticancer therapy (platin based, immunotherapy, combined therapy or TKI), for recurrent cancer, this goes only for WP2X. * Having a staging/baseline CT within 4 weeks of initiation of treatment (PET/CT are also allowed), or a baseline scan planned within the first week of treatment. * ECOG Performance Status 0-2 * Having signed the informed consent form Exclusion Criteria, WP1+WP2X+WP2: * Any other known malignancy requiring active treatment (prior cancer diagnosis is not some exclusion criteria if oncology-treatment is completed) * Local palliative radiotherapy as primary treatment * ECOG Performance status \> 2 * Physical disabilities excluding physical testing * Inability to understand Danish * Inability to understand scoring systems/patient-reported outcome measures Inclusion Criteria, WP3: * Men and women above the age of 18 * Histological and radiological verified NSCLC (both squamous and adenocarcinoma) st. IIIb/IV stage * ECOG Performance Status 0-2 * Having signed the informed consent form. Exclusion Criteria, WP3: * Any other known malignancy requiring active treatment (prior cancer diagnosis is not some exclusion criteria if oncology-treatment is completed) * ECOG Performance Status \> 2 * Physical disabilities excluding physical testing * Inability to understand Danish * Inability to understand scoring systems/patient-reported outcome measures
Where this trial is running
Copenhagen, DK
- University of Copenhagen — Copenhagen, Dk, Denmark (Recruiting)
Study contacts
- Principal investigator: Lykke Sylow, Ass.proff. — University of Copenhagen
- Study coordinator: Jonas Sørensen, MD.
- Email: jonas.soerensen@sund.ku.dk
- Phone: 0045-51513480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.