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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
  1. Eric Lambaudie1,2,
  2. Cécile Bannier/Braticevic3,
  3. Charlène Villaron/Goetgheluck4,
  4. Christophe Zemmour5,
  5. Jean-Marie Boher5,
  6. Patrick Ben Soussan6,
  7. Jihane Pakradouni7,
  8. Clement Brun8,
  9. Leonor Lopez Almeida7 and
  10. Patricia Marino2,9
  1. 1Department of Surgery, Institut Paoli-Calmettes, Marseille, France
  2. 2Aix Marseille University, INSERM, IRD, SESSTIM, Marseille, France
  3. 3Department of Oncology, Paoli-Calmettes Institute, Marseille, France
  4. 4Management Sport and Cancer Laboratory EA4670, Paoli-Calmettes Institute, Marseille, France
  5. 5Department of Clinical Research and Innovation, Statistics and Methodology Unit, Paoli-Calmettes Institute, Marseille, France
  6. 6Department of Clinical Psychology, Paoli-Calmettes Institute, Marseille, France
  7. 7Department of Clinical Research and Innovation, Paoli-Calmettes Institute, Marseille, France
  8. 8Department of Anesthesiology, Paoli-Calmettes Institute, Marseille, France
  9. 9SESSTIM U1252, Paoli-Calmettes Institute, Marseille, France
  1. Correspondence to Professor Eric Lambaudie, Department of Surgery, Institut Paoli-Calmettes, Marseille 13009, France; lambaudiee{at}ipc.unicancer.fr

Abstract

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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Footnotes

  • 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.

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