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

NCT ID: NCT05415527

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-11
• Study Completion Date: 2028-06-10

Brief Summary

Prospective, monocentric study evaluating the presence of sarcopenia prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management.

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.

Conditions

Ovarian Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

patients with inoperable high-grade ovarian carcinoma

Evaluation of sarcopenia in patients with inoperable high-grade ovarian carcinoma as part of optimised management

Group Type: OTHER

Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA).

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pierre GEKIERE, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Bergonié

Locations

Institut Bergonié

Bordeaux, , France

Countries

France

Other Identifiers

IB2021-05

Identifier Type: -

Identifier Source: org_study_id