Exercise program to reduce lasting tiredness after metastatic testicular cancer
Tests a supervised exercise program for fatigue in men with metastatic testicular cancer.
Key facts
- Who runs it
- Centre Leon Berard
- Where
- France12 sites in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients
- Status
- Recruiting
- People taking part
- 236 people, planned
- Started
- 14 Jan 2025
- Expected to end
- 14 Jan 2038
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Physical activity recommendations
- Connected activity tracker
- Physical Activity (PA) Intervention
- Record updated
- 31 March 2026
Who can take part
- Age
- 18 years and older
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- Concurrent participation in another study in PA
- 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),
- Presence of symptomatic bone and/or brain metastases
- Central nervous system involvement with neurological deficits preventing walking
- 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,
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Testicular germ cell tumor (TGCT) is the most common malignancy in men between 15 and 40 years. Although TCGT survivors have a good survival prognosis, they suffer from short- and long-term sequelae such as chronic fatigue, psychological disorders, cardiovascular toxicities and second malignancies. The benefits of physical activity (PA) during treatments have been demonstrated in cancer patients to improve quality of life (QoL) and physical fitness and to reduce fatigue. However, few PA programs have been proposed to TGCT patients and their effects on sequelae have not been assessed yet. A growing body of evidence links treatment-related alteration in the gut microbiota to sequelae of cancer survivors, including fatigue and cardiovascular toxicities. Also, PA has been known as a possible modulator of the gut microbiota composition. To date, no study has been conducted to examine how the gut microbiota and its metabolites moderate the effect of PA on fatigue and other late effects in TGCT survivors. The objectives will be to assess the impact of a PA program on fatigue and other sequelae and to investigate how the gut microbiota and its metabolites moderate the associations between PA and sequelae. We will conduct a prospective, multicenter, phase III, randomized controlled trial of a one-year supervised PA program. 236 men with metastatic TGCT and eligible for a first line of chemotherapy will be randomly assigned to either PA intervention or control arm. All patients will benefit from a connected activity tracker and PA recommendations. In the intervention arm, PA will be based on supervised sessions and motivational interviews. The primary endpoint (fatigue) will be assessed at 3 years. The trial will provide novel insights into the impact of PA on fatigue and other sequelae in TGCT survivors with understanding a potential underlying mechanism of gut microbiota. This evidence will support the development of targeted PA guidelines to improve QoL and reduce sequelae in TGCT survivors.
The 2 groups in the trial
- Control groupExisting treatment, for comparison
Treatment: Physical activity recommendations and Connected activity tracker
- Intervention groupTreatment being tested
Treatment: Physical activity recommendations, Connected activity tracker, and Physical Activity (PA) Intervention
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Exercise program to reduce lasting tiredness after metastatic testicular cancerGenerated from the registry record. The registry title is the official one.
- Record updated
- 31 March 2026