RT Journal Article
SR Electronic
T1 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
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP 920
OP 924
DO 10.1136/ijgc-2020-002128
VO 31
IS 6
A1 Lambaudie, Eric
A1 Bannier/Braticevic, Cécile
A1 Villaron/Goetgheluck, Charlène
A1 Zemmour, Christophe
A1 Boher, Jean-Marie
A1 Ben Soussan, Patrick
A1 Pakradouni, Jihane
A1 Brun, Clement
A1 Lopez Almeida, Leonor
A1 Marino, Patricia
YR 2021
UL http://ijgc.bmj.com/content/31/6/920.abstract
AB Background Patients 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 hypothesis A pre-habilitation program during neoadjuvant chemotherapy will bring a fitter patient to surgery and will decrease treatment morbidity and improve oncological outcomes.Trial design This 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 criteria Eligible 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 size 136 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 results The duration of the study includes 24 months of recruitment and 5 years of follow up. We anticipate reporting primary endpoint results in 2024.Trial registration TRAINING-01-IPC 2018-039 (NCT04451369).Data are available upon request.