Informations générales (source: ClinicalTrials.gov)
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
Interventional
N/A
Centre Leon Berard (Voir sur ClinicalTrials)
janvier 2025
janvier 2038
16 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Anna PATRIKIDOU | 03/07/2026 09:05:05 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Agnès DUCOULOMBIER, MD | Contact (sur clinicalTrials) | |||
| Centre Eugène Marquis - 35000 - Rennes - France | Christophe MASSARD, PhD, MD | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - 14076 - Caen - France | Florence JOLY, Pr, MD | Contact (sur clinicalTrials) | |||
| Centre Leon Berard - 69008 - Lyon - France | Aude FLECHON, MD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59020 - Lille - France | Guillaume CARBONNELLE, MD | Contact (sur clinicalTrials) | |||
| CHU Jean Minjoz - 25030 - Besançon - France | Guillaume MOUILLET, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonié - 33000 - Bordeaux - France | Mathilde CABART, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - 54519 - Nancy - France | Lionnel Goeffrois, MD | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion Criteria:
- Men ≥18 years
- With a metastatic germ cell tumor histologically confirmed (seminoma and
non-seminoma)
- Who have already undergone an orchidectomy
- 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.
- Men ≥18 years
- With a metastatic germ cell tumor histologically confirmed (seminoma and
non-seminoma)
- Who have already undergone an orchidectomy
- 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.
- 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.