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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Prehabilitation program

    Other intervention

    physical, nutritional and psycho-social supports before surgery

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Prehabilitation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
baseline, 15 days before surgery and 3 moths before surgery

Secondary outcomes

1

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

Time frame
baseline, before surgery, and 3 months after surgery
2

to compare physical outcomes between both groups

Muscular strength evaluated with dynamometer (brachial biceps)

Time frame
baseline, before surgery, and 3 months after surgery
3

to compare Quality of Life, emotional outcomes between both groups

Psychological status evaluated by the Hospital Anxiety and Depression Scale (HADS) (Annex 2)

Time frame
baseline, before surgery, and 3 months after surgery
4

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)

Time frame
baseline, before surgery, and 3 months after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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