Prehabilitation program
Otherphysical, nutritional and psycho-social supports before surgery
NCT Number: NCT04451369
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
The main objective will be to determine if a prehabilitation program during NACT, for patients treated for an advanced ovarian cancer will limit physical alteration before major abdomino-pelvic surgery, compared to a control group without prehabilitation program. The primary endpoint will be the comparison of the variation of VO2 max, between baseline and surgery, in the prehabilitation group vs control group: VO2 max will be measured with a cardiopulmonary exercise test (CPET) at maximal effort.
This prospective, multicentric randomized control trial will be conducted in 7 French comprehensive cancer Centers or University Hospital, in compliance with inclusion criteria. After an initial evaluation, patients will be randomized in two groups: Prehabilitation group (P group) and a Control group (C group).
For the P group, after baseline evaluation, we will be offering from diagnosis to surgery, during the NACT:
For the C group: Patients with ovarian cancer will undergo NACT after baseline evaluation without prehabilitation program.
After NACT, for both groups, major abdomino-pelvic surgery will be done with or without ERAS pathway, according to the practice in each center.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
physical, nutritional and psycho-social supports before surgery
Time frame: baseline, 15 days before surgery and 3 moths before surgery
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, before surgery, and 3 months after surgery
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
Muscular strength evaluated with dynamometer (brachial biceps)
Time frame: baseline, before surgery, and 3 months after surgery
Psychological status evaluated by the Hospital Anxiety and Depression Scale (HADS) (Annex 2)
Time frame: baseline, before surgery, and 3 months after surgery
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
Motivation evaluated by a free interview and a coping strategy.
Time frame: baseline, before surgery, and 3 months after surgery
Change Body Mass Index (BMI)
Time frame: baseline, before surgery, and 3 months after surgery
Muscle mass evaluated with the Computed tomography-derived
Time frame: baseline, before surgery, and 3 months after surgery
skeletal muscle index measured by skeletal muscle mass cross-sectional area at L3/height2
Time frame: baseline, before surgery, and 3 months after surgery
Weight in kg
Time frame: at day 30 and day 90 (3 months) after surgery
Clavien-Dindo classification
Time frame: at day 30 and day 90 (3 months) after surgery
NCI-CTCAE v 5.0 classification
Contact information is provided by the study sponsor or research team.
Institut Paoli-Calmettes
Other
Multicenter Randomized Study Comparing Neo Adjuvant Chemotherapy for Patients Managed for Ovarian Cancer With or Without a Connected Prehabilitation Program
Acronym: TRAINING
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