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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Prehabilitation program
Other interventionphysical, nutritional and psycho-social supports before surgery
Treatment groups
Trial outcomes
Primary outcomes
To determine if a prehabilitation program during NACT, for patient managed with advanced ovarian cancer (AOC) will limit physical alteration before surgery, compared to a control group without prehabilitation program (change between 3 timepoints).
CHANGE of VO2 max between baseline (inclusion) and surgery (preoperative), in the prehabilitation group vs control group. VO2 max will be measured during a cardiopulmonary exercise test (CPET).
Secondary outcomes
to compare physical outcomes between both groups
o International Physical Activity Questionnaire (IPAQ) , administered at inclusion and at the time of surgery and after surgery
to compare physical outcomes between both groups
Muscular strength evaluated with dynamometer (brachial biceps)
to compare Quality of Life, emotional outcomes between both groups
Psychological status evaluated by the Hospital Anxiety and Depression Scale (HADS) (Annex 2)
to compare Quality of Life, emotional outcomes between both groups
Cancer related quality of life (QoL) evaluated by using the self-reported European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30) (Annex 3)
Locations
Sponsors and contacts
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