Clinical trial · Interventional
Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Testicular Cancer | Malignant Testicular Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Connected activity tracker | Behavioral | — | UNRESOLVED |
| Physical Activity (PA) Intervention | Behavioral | — | UNRESOLVED |
| Physical activity recommendations | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control group
- interventionNames
- Behavioral: Physical activity recommendations
- Behavioral: Connected activity tracker
- type
- EXPERIMENTAL
- label
- Intervention group
- interventionNames
- Behavioral: Physical activity recommendations
- Behavioral: Connected activity tracker
- Behavioral: Physical Activity (PA) Intervention
Primary outcomes (1)
- measure
- cancer-related fatigue, considering both physical and cognitive fatigue scores at 3 years after the start of first-line chemotherapy
- timeFrame
- Year 3
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDNoh H, Anota A, Mongondry R, Meyrand R, Dupuis C, Schiffler C, Marijnen P, Rinaldi S, Lachuer J, Keski-Rahkonen P, Gunter MJ, Flechon A, Fervers B, Perol O. Impact of a one-year supervised physical activity program on long-term cancer-related fatigue and mediating effects of the gut microbiota in metastatic testicular cancer patients: protocol of the prospective multicentre, randomized controlled phase-III STARTER trial. BMC Cancer. 2024 Jan 15;24(1):84. doi: 10.1186/s12885-024-11824-7. PMID 38225551