Clinical trial · Interventional
Connected Prehabilitation Program During Neo Adjuvant Chemotherapy
Multicenter Randomized Study Comparing Neo Adjuvant Chemotherapy for Patients Managed for Ovarian Cancer With or Without a Connected Prehabilitation Program
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- Group without prehabilitation program before surgery
- type
- EXPERIMENTAL
- label
- Prehabilitation group
- description
- Group will follows a prehabilitation program before surgery
- interventionNames
- Other: Prehabilitation program
Primary outcomes (1)
- measure
- 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).
- timeFrame
- baseline, 15 days before surgery and 3 moths before surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient must have signed the written consent, 2. Age ≥ 18 years, 3. Patient with advanced ovarian cancer (AOC), FIGO Stage III - IV, undergoing surgery, 4. Patient with neo adjuvant chemotherapy (min 3 cycles, max 6 cycles), 5. Capability to perform a cardiopulmonary exercise test (CPET) 6. Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen. Exclusion Criteria: 1. Patient with cognitive impairment, 2. Pregnancy, 3. Neoadjuvant treatment contraindications, 4. Physical adapted activity program contraindication, 5. No possibility to have access to connected devices or do not have a smartphone or a computer 6. Patient deprived of liberty or placed under the authority of a tutor, 7. Patient considered socially or psychologically unable to comply with the procedure and the required medical follow-up.
References
Publications (1)
- DERIVEDLambaudie E, Bannier/Braticevic C, Villaron/Goetgheluck C, Zemmour C, Boher JM, Ben Soussan P, Pakradouni J, Brun C, Lopez Almeida L, Marino P. 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. Int J Gynecol Cancer. 2021 Jun;31(6):920-924. doi: 10.1136/ijgc-2020-002128. Epub 2020 Dec 1. PMID 33262113