Condition: Metastatic Testicular Cancer · Sponsor: Centre Leon Berard
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 be…
This description comes directly from the study's public registry record.
Carmen Dupuis, PhD · 0469856218 · carmen.dupuis@lyon.unicancer.fr
Olivia Pérol, PhD · 0478782897 · olivia.perol@lyon.unicancer.fr
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| 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 |
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Source record: clinicaltrials.gov/study/NCT05588700