Connected Prehabilitation Program During Neo Adjuvant Chemotherapy

NCT04451369 | Not Yet Recruiting

• 1 other identifier: TRAINING-01-IPC 2018-039
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Ovarian Cancer

Outcome Measures

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).

  baseline, 15 days before surgery and 3 moths before surgery

Secondary Outcomes (11)

• to compare physical outcomes between both groups

  baseline, before surgery, and 3 months after surgery

• to compare physical outcomes between both groups

  baseline, before surgery, and 3 months after surgery

• to compare Quality of Life, emotional outcomes between both groups

  baseline, before surgery, and 3 months after surgery

• to compare Quality of Life, emotional outcomes between both groups

  baseline, before surgery, and 3 months after surgery

• to compare Quality of Life, emotional outcomes between both groups

  baseline, before surgery, and 3 months after surgery

Study Arms (2)

Control group

NO INTERVENTION

Group without prehabilitation program before surgery

Prehabilitation group

EXPERIMENTAL

Group will follows a prehabilitation program before surgery

Other: Prehabilitation program

Interventions

Prehabilitation program OTHER

physical, nutritional and psycho-social supports before surgery

Prehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Ovarian cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient with cognitive impairment,
• 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.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Related Publications (1)

• Lambaudie 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 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Dominique GENRE, Dr

CONTACT

+33 4 91 22 37 78; drci.up@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 30, 2020
• Study Start: May 1, 2021
• Primary Completion: September 1, 2022
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 10, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share