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).
- ovarian cancer
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Contributors Study concept and design: all authors. Acquisition of data: JP, LLA, PM. Analysis and interpretation of data: CZ, JMB. Drafting/final editing: EL, PM. Critical revision: all authors. Tables and figures: EL, CBB, LLA.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval Ethics approval was obtained from the Institutional Review Board of Paoli Calmettes Institute (IPC 2018–039) and the National Ethics Committee (2020/99).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon request.