TRAINING-Ovary 01 (connecTed pRehabiliAtIoN pelvIc caNcer surGery): multicenter randomized study comparing neoadjuvant chemotherapy for patients managed for ovarian cancer with or without a connected pre-habilitation program
| Autor: | Leonor Lopez Almeida, Eric Lambaudie, Clément Brun, Braticevic, Goetgheluck, Charlène Villaron, Patricia Marino, Christophe Zemmour, Cécile Bannier, Jihane Pakradouni, Jean-Marie Boher, Patrick Ben Soussan |
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| Přispěvatelé: | Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Sport, Management, Gouvernance, Performance (SMGP), Aix Marseille Université (AMU)-Institut d'Études Politiques [IEP] - Aix-en-Provence, Malbec, Odile |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
[SDV]Life Sciences [q-bio] medicine.medical_treatment education.educational_degree Habilitation law.invention Randomized controlled trial law medicine Clinical endpoint Humans Prospective Studies Stage (cooking) education Ovarian Neoplasms Chemotherapy business.industry Preoperative Exercise Obstetrics and Gynecology VO2 max medicine.disease Neoadjuvant Therapy Surgery [SDV] Life Sciences [q-bio] ovarian cancer Oncology Sample size determination Female business Ovarian cancer |
| Zdroj: | International Journal of Gynecological Cancer International Journal of Gynecological Cancer, 2021, 31 (6), pp.920-924. ⟨10.1136/ijgc-2020-002128⟩ |
| ISSN: | 1525-1438 1048-891X |
| DOI: | 10.1136/ijgc-2020-002128 |
| Popis: | BackgroundPatients undergoing neoadjuvant chemotherapy before surgery for advanced ovarian cancer may have impaired functional capacity, nutritional status, and emotional well-being.Primary objective(s)TRAINING-01 aims to determine if a connected pre-habilitation program during neoadjuvant chemotherapy for patients treated for an advanced ovarian cancer will improve physical capacity before major abdomino-pelvic surgery.Study hypothesisA pre-habilitation program during neoadjuvant chemotherapy will bring a fitter patient to surgery and will decrease treatment morbidity and improve oncological outcomes.Trial designThis study is a prospective, multi-center, phase III study. The pre-habilitation program consists of providing multi-dimensional support during neoadjuvant chemotherapy using connected devices. The control group will receive usual care.Major inclusion/exclusion criteriaEligible patients will be women with International Federation of Gynecology and Obstetrics stage III–IV advanced ovarian cancer undergoing neoadjuvant chemotherapy. Patients must be able to perform a cardiopulmonary exercise test.Primary endpoint(s)The primary endpoint will be the comparison of the variation in maximum oxygen uptake (VO2 max) between baseline and surgery in the pre-habilitation group and control groups.Sample size136 patients (68 per arm) will be recruited to demonstrate a medium standardized effect d=0.5 in the variations of VO2 max between baseline and surgery.Estimated dates for completing accrual and presenting resultsThe duration of the study includes 24 months of recruitment and 5 years of follow up. We anticipate reporting primary endpoint results in 2024.Trial registrationTRAINING-01-IPC 2018-039 (NCT04451369). |
| Databáze: | OpenAIRE |
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