NCT04451369Not yet recruiting
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 · Last updated 10 Feb 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 3 Jun 2020
- Start date
- May 2021
- Primary completion date
- Sept 2022
- Lead sponsor
- Institut Paoli-Calmettes
- Diseases
- Ovarian cancer
- NCT number
- NCT04451369
What you commit to
- Study type: Interventional
- Planned participants: 136
- From May 2021 to the primary completion date, Sept 2022
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient with cognitive impairment,
Other
- Pregnancy,
- Neoadjuvant treatment contraindications,
- Physical adapted activity program contraindication,
- No possibility to have access to connected devices or do not have a smartphone or a computer
- Patient deprived of liberty or placed under the authority of a tutor,
- Patient considered socially or psychologically unable to comply with the procedure and the required medical follow-up.
Who the study is looking for
- 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),
- Capability to perform a cardiopulmonary exercise test (CPET)
- Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.