Evaluation of Pretreatment Sarcopenia in Patients With Inoperable High-grade Ovarian Carcinoma as Part of Optimised Management (OPTIMOVA)

January 28, 2026 updated by: Institut Bergonié
Prospective, monocentric study evaluating the presence of sarcopenia prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and constraints of the study.

Before inclusion,all eligibility criteria will be verified.

Sarcopenia in patients with inoperable, high-grade epithelial ovarian carcinoma will be evaluated at different times:

  • before treatment, in the 30 days prior to their inclusion in the study,
  • after 3 neoadjuvant chemotherapy cycles,
  • after 3 adjuvant chemotherapy cycles,
  • 9 months after surgery. The reference detection method is by CT-scan. This will be combined with a bone mineral density test which is also a way of entering into a more specific approach to sarcopenia screening.

On inclusion, the patients will receive optimised treatment by nutritional monitoring and adapted physical activity (APA) in addition to follow-up for sarcopenia.

This follow-up by a dietician and a physical fitness trainer will be recorded at each neoadjuvant chemotherapy session.

Dietary advice will be given each time along with personalised advice if weight loss were to be observed.

If undernutrition or a foreseeable risk of undernutrition are diagnosed, parenteral nutrition will be prescribed by the oncologist, the anaesthetist or the surgeon.

The objective of APA is to prevent the onset or aggravation of disease, to increase patient autonomy and quality-of-life, or even to help them return to social activities.

Respiratory preparation will also be offered to increase the patient's respiratory capacity in view of surgery, with exercises to be done using a respiratory training device.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Institut Bergonie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Inoperable, high-grade, epithelial ovarian carcinoma requiring perioperative chemotherapy (neoadjuvant and adjuvant).
  3. Optical medical treatment (carboplatin-taxol chemotherapy every 3 weeks) and surgery at Institut Bergonié.
  4. Non-clinically undernourished patient, i.e. without loss of more than 10% bodyweight in 6 months
  5. Free, informed and written consent signed by the participant and the investigator (on the day of inclusion at the latest and before any tests required for the research).
  6. Patient with social security cover in accordance with Article 1121-11 of the French code of public health.

Exclusion Criteria:

  1. Contraindication to CT-scans.
  2. Contraindication to bone mineral densitometry.
  3. Patients over the age of 70 the G8 of whom requires oncogeriatric surgery.
  4. Patients under guardianship, vulnerable patients or patients under any other legal protection measures.
  5. Geographic, social or psychological factors meaning the patient is unable to commit to study follow-up and procedures.
  6. Patient already included in this study or in another study evaluating the impact of sarcopenia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patients with inoperable high-grade ovarian carcinoma
Evaluation of sarcopenia in patients with inoperable high-grade ovarian carcinoma as part of optimised management
Other: Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA).

Sarcopenia will be evaluated by CT-scan. This method will be combined with a bone mineral density test which is also a way of entering into a more specific approach to sarcopenia screening.

The patients will receive optimised treatment by nutritional monitoring and adapted physical activity (APA) in addition to follow-up for sarcopenia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with pretreatment sarcopenia identified by analysis of the baseline CT-scan (CT0).
Time Frame: Baseline
Proportion of patients with pretreatment sarcopenia identified by analysis of the baseline CT-scan (CT0). According to the 2019 HAS guidelines [Diagnosis of undernutrition in children and adults, November 2019], we consider the patient to have sarcopenia if her MSI is strictly below 38.5 cm2/m2.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time of access to chemotherapy
Time Frame: From the date of surgery to the start date of adjuvant chemotherapy, assessed up to 2 months from surgery
The time of access to chemotherapy is the time between the date of surgery and the adjuvant chemotherapy start date. Pretreatment sarcopenia is defined as for the primary endpoint.
From the date of surgery to the start date of adjuvant chemotherapy, assessed up to 2 months from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Investigators

  • Principal Investigator: Jean-Pierre GEKIERE, MD, Institut Bergonie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2022

Primary Completion (Estimated)

June 10, 2027

Study Completion (Estimated)

June 10, 2028

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2021-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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