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AzTrials

Ovarian CancerTRAININGNCT04451369

Connected Prehabilitation Program During Neo Adjuvant Chemotherapy

A study testing Prehabilitation program in people with Ovarian Cancer, run by Institut Paoli-Calmettes.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Prehabilitation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
No sites listed yet
Study dates
May 2021to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Dominique GENRE, Dr contact

+33 4 91 22 37 78

drci.up@ipc.unicancer.fr

About this study

Official title: 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.

Read more

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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
Prehabilitation program
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prehabilitation programOther

    physical, nutritional and psycho-social supports before surgery

Study groups in NCT04451369
Study groupRoleWhat they receive
Control groupNo interventionGroup without prehabilitation program before surgery
Prehabilitation groupExperimentalGroup will follows a prehabilitation program before surgery
Receives: Other: Prehabilitation program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: baseline, 15 days before surgery and 3 moths before surgery

Secondary outcomes (11)

  1. to compare physical outcomes between both groups

    • International Physical Activity Questionnaire (IPAQ) , administered at inclusion and at the time of surgery and after surgery

    Measured: baseline, before surgery, and 3 months after surgery

  2. to compare physical outcomes between both groups

    Muscular strength evaluated with dynamometer (brachial biceps)

    Measured: baseline, before surgery, and 3 months after surgery

  3. to compare Quality of Life, emotional outcomes between both groups

    Psychological status evaluated by the Hospital Anxiety and Depression Scale (HADS) (Annex 2)

    Measured: baseline, before surgery, and 3 months after surgery

  4. 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)

    Measured: baseline, before surgery, and 3 months after surgery

  5. to compare Quality of Life, emotional outcomes between both groups

    Motivation evaluated by a free interview and a coping strategy.

    Measured: baseline, before surgery, and 3 months after surgery

  6. to compare nutritional outcomes between both groups

    Change Body Mass Index (BMI)

    Measured: baseline, before surgery, and 3 months after surgery

  7. to compare nutritional outcomes between both groups

    Muscle mass evaluated with the Computed tomography-derived

    Measured: baseline, before surgery, and 3 months after surgery

  8. to compare nutritional outcomes between both groups

    skeletal muscle index measured by skeletal muscle mass cross-sectional area at L3/height2

    Measured: baseline, before surgery, and 3 months after surgery

  9. to compare nutritional outcomes between both groups

    Weight in kg

    Measured: baseline, before surgery, and 3 months after surgery

  10. to compare Surgical Morbidity rate between both groups

    Clavien-Dindo classification

    Measured: at day 30 and day 90 (3 months) after surgery

  11. to compare Surgical Morbidity rate between both groups

    NCI-CTCAE v 5.0 classification

    Measured: at day 30 and day 90 (3 months) after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study startMay 2021 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04451369
Sponsor's protocol ID
TRAINING-01-IPC 2018-039
Acronym
TRAINING
Status last verified
May 2020
First submitted
3 Jun 2020
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 33262113

Questions about this trial

What is this clinical trial studying?

A study testing Prehabilitation program in people with Ovarian Cancer, run by Institut Paoli-Calmettes.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dominique GENRE, Dr (+33 4 91 22 37 78, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). (time frame: baseline, 15 days before surgery and 3 moths before surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04451369, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.

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