Connected Prehabilitation Program During Neo Adjuvant Chemotherapy (TRAINING)

• ClinicalTrials.gov Identifier: NCT04451369
• Recruitment Status: Not yet recruiting
• First Posted: June 30, 2020
• Last Update Posted: June 30, 2020
• Sponsor: Institut Paoli-Calmettes
• Information provided by (Responsible Party): Institut Paoli-Calmettes

Tracking Information

• First Submitted Date: June 3, 2020
• First Posted Date: June 30, 2020
• Last Update Posted Date: June 30, 2020
• Estimated Study Start Date: October 2020
• Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 25, 2020)

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). [ 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).

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 25, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Connected Prehabilitation Program During Neo Adjuvant Chemotherapy
• Official Title: Multicenter Randomized Study Comparing Neo Adjuvant Chemotherapy for Patients Managed for Ovarian Cancer With or Without a Connected Prehabilitation Program

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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Ovarian Cancer

Intervention

Other: Prehabilitation program

physical, nutritional and psycho-social supports before surgery

Study Arms

• No Intervention: Control group
  Group without prehabilitation program before surgery
• Experimental: Prehabilitation group
  Group will follows a prehabilitation program before surgery
  Intervention: Other: Prehabilitation program

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: June 25, 2020): 136
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2027
• Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Ovarian cancer.

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Dominique GENRE, Dr; +33 4 91 22 37 78; drci.up@ipc.unicancer.fr

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04451369
• Other Study ID Numbers: TRAINING-01-IPC 2018-039
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Institut Paoli-Calmettes
• Study Sponsor: Institut Paoli-Calmettes
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Institut Paoli-Calmettes
• Verification Date: May 2020