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

Ovarian Carcinoma Clinical Trial

— OPTIMOVA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415527
• Other study ID #: IB2021-05
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2022
• Est. completion date: January 2026

Study information

• Verified date: March 2023
• Source: Institut Bergonié
• Contact: Jean-Pierre GEKIERE, MD
• Phone: 05 56 33 33 47
• Email: j.gekiere[@]bordeaux.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: January 2026
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ovarian Epithelial
• Ovarian Carcinoma
• Ovarian Neoplasms
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with pretreatment sarcopenia identified by analysis of the baseline CT-scan (CT0).	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	The time of access to chemotherapy	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