Physical activity program to reduce cancer-related fatigue in men with metastatic testicular cancer
A National, Multicenter, Phase III Randomized Controlled Trial to Assess the Impact of a One-year Supervised Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients
This study is testing whether a physical activity program can help men with metastatic testicular cancer feel less tired and improve their overall quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 236 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Centre Leon Berard Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 12 sites (Angers and 11 other locations) |
| Trial ID | NCT05588700 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a physical activity program on reducing long-term cancer-related fatigue in men diagnosed with metastatic testicular germ cell tumors. Participants will engage in a structured physical activity intervention, monitored through connected activity trackers, to assess improvements in fatigue and overall quality of life. The study also aims to explore the relationship between physical activity, gut microbiota composition, and the sequelae experienced by cancer survivors. By focusing on this specific patient population, the study seeks to fill a gap in existing research regarding the benefits of physical activity for testicular cancer survivors.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with a confirmed diagnosis of metastatic germ cell tumor who have undergone orchidectomy and are scheduled for first-line chemotherapy.
Not a fit: Patients with symptomatic bone or brain metastases or those with neurological deficits preventing physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and reduce fatigue for patients recovering from metastatic testicular cancer.
How similar studies have performed: While there is growing evidence supporting the benefits of physical activity in cancer patients, this specific approach focusing on testicular cancer survivors is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men ≥18 years * With a metastatic germ cell tumor histologically confirmed (seminoma and non-seminoma) * Who have already undergone an orchidectomy (since the 16th december, this criteria was deleted). * Having a first line of chemotherapy planned with BEP, EP or VIP * Having a smartphone (i.e. to connect the activity tracker) * PS \< or = 2 * Whose ability to practice an adapted physical activity (APA) has been certified by a medical certificate issued by the referring oncologist or the investigating physician * Available and willing to participate in the study for the duration of the intervention and follow-up, * Able to understand, read and write French, * Affiliated with a social security scheme, * Having dated and signed an informed consent. Exclusion Criteria: * Presence of symptomatic bone and/or brain metastases * Central nervous system involvement with neurological deficits preventing walking * History or coexistence of another primary cancer (apart from in situ cancer of any location and/or basal cell skin cancer and/or basal cell skin cancer and/or a cancer in complete remission for more than 3 years), * Contraindication to physical activity (e.g. uncontrolled hypertension, uncontrolled heart disease) uncontrolled heart disease), * Unable to be followed for medical, social, family, geographical or psychological reasons, during the entire study period, * Deprived of liberty by judicial or administrative decision, or adults protected by law, * Concurrent participation in another study in PA.
Where this trial is running
Angers and 11 other locations
- Institut de Cancérologie de Lorraine — Angers, France (Not_yet_recruiting)
- CHU Jean Minjoz — Besançon, France (Not_yet_recruiting)
- Institut Bergonié — Bordeaux, France (Not_yet_recruiting)
- Centre François Baclesse — Caen, France (Not_yet_recruiting)
- Centre Oscar Lambret — Lille, France (Not_yet_recruiting)
- Centre Leon Berard — Lyon, France (Recruiting)
- Institut de Cancérologie de Lorraine — Nancy, France (Recruiting)
- Centre Antoine Lacassagne — Nice, France (Not_yet_recruiting)
- AP-HP Tenon — Paris, France (Not_yet_recruiting)
- Centre Eugène Marquis — Rennes, France (Not_yet_recruiting)
- CHU Tours — Tours, France (Not_yet_recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Principal investigator: Aude Fléchon, MD — Centre Leon Berard
- Study coordinator: Carmen Dupuis, PhD
- Email: carmen.dupuis@lyon.unicancer.fr
- Phone: 0469856218
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.