Connected Prehabilitation Program During Neo Adjuvant Chemotherapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut Paoli-Calmettes

About this trial

NACT is a heavy oncologic treatment, which can impair functional capacity, nutritional and emotional status. These three impairments are often ignored and not taken into account in the pre-therapeutic evaluations but are correlated with postoperative morbidity and mortality after major surgery.

Recently, a prehabilitation before surgery, including physical, nutritional and psycho-social support, has been defined. From a literature review, the maximum oxygen uptake (VO2 max) seems to constitute a strong evaluation factor reflecting physical fitness, easily measured with a cardiopulmonary exercise test (CPET) at maximal effort.

Several studies have shown beneficial effects of trimodal prehabilitation programs on postoperative functional capacity, return to daily activities and pain relief.

Home-based program and connected devices may improve the feasibility and the compliance to this program.

The hypothesis of this study is that performing a connected supervised home-based and patient-tailored multimodal prehabilitation program from diagnosis to surgery (with or without ERAS program) during NACRT, for patients managed for ovarian cancer, will limit physical fitness alteration and will positively affect postoperative outcomes.

Our study consists in an early and multidimensional (combining nutritional, physical, emotional and medical support) prehabilitation program during NACT for patients with ovarian cancer, in order to limit physical alteration before surgical treatment, and therefore improve postoperative outcomes. It will include a home-based prehabilitation program, in order to allow care access to all eligible patients.

Eligibility criteria

Qualifiers

Patient must have signed the written consent,

Age ≥ 18 years,

Patient with advanced ovarian cancer (AOC), FIGO Stage III - IV, undergoing surgery,

Patient with neo adjuvant chemotherapy (min 3 cycles, max 6 cycles),

Disqualifiers

Patient with cognitive impairment,

Pregnancy,

Neoadjuvant treatment contraindications,

Physical adapted activity program contraindication,

Trial design

Treatments tested in this trial

  • Prehabilitation program

Treatment groups

136 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators