Connected Prehabilitation Program During Neo Adjuvant Chemotherapy (TRAINING)

Multicenter Randomized Study Comparing Neo Adjuvant Chemotherapy for Patients Managed for Ovarian Cancer With or Without a Connected Prehabilitation Program

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Other: Prehabilitation program

Detailed Description

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:

• A standardized, patient-tailored preoperative physical activity training program will be performed at home, from diagnosis to surgery. Supervision will be done with connected device (connected watches) and activity will be adapted,
• A nutritional care established in respect of the SFNEP-SFNCM guidelines. Nutritional support will be adapted by a dietician according to information transmitted daily (connected body fat weight scale),
• A psychological support with coping strategies.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominique GENRE, Dr; Phone Number: +33 4 91 22 37 78; Email: drci.up@ipc.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group; Group without prehabilitation program before surgery
EXPERIMENTAL: Prehabilitation group; Group will follows a prehabilitation program before surgery	Other: Prehabilitation program; physical, nutritional and psycho-social supports before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline, before surgery, and 3 months after surgery
to compare physical outcomes between both groups	Muscular strength evaluated with dynamometer (brachial biceps)	baseline, before surgery, and 3 months after surgery
to compare Quality of Life, emotional outcomes between both groups	Psychological status evaluated by the Hospital Anxiety and Depression Scale (HADS) (Annex 2)	baseline, before surgery, and 3 months after surgery
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)	baseline, before surgery, and 3 months after surgery
to compare Quality of Life, emotional outcomes between both groups	Motivation evaluated by a free interview and a coping strategy.	baseline, before surgery, and 3 months after surgery
to compare nutritional outcomes between both groups	Change Body Mass Index (BMI)	baseline, before surgery, and 3 months after surgery
to compare nutritional outcomes between both groups	Muscle mass evaluated with the Computed tomography-derived	baseline, before surgery, and 3 months after surgery
to compare nutritional outcomes between both groups	skeletal muscle index measured by skeletal muscle mass cross-sectional area at L3/height2	baseline, before surgery, and 3 months after surgery
to compare nutritional outcomes between both groups	Weight in kg	baseline, before surgery, and 3 months after surgery
to compare Surgical Morbidity rate between both groups	Clavien-Dindo classification	at day 30 and day 90 (3 months) after surgery
to compare Surgical Morbidity rate between both groups	NCI-CTCAE v 5.0 classification	at day 30 and day 90 (3 months) after surgery

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2027

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (ACTUAL): June 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: TRAINING-01-IPC 2018-039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No