NCT05415527

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-11
• Primary completion: 2027-06-10
• Completion: 2028-06-10
• First posted: 2022-06-13
• Last updated: 2026-01-29

Locations

1 site across 1 country: France