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Completed
NCT05415527
Evaluation of Pretreatment Sarcopenia in Patients With Inoperable High-grade Ovarian Carcinoma as Part of Optimised Management
Conditions: Ovarian Carcinoma
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Institut Bergonié
Location: Institut Bergonié Bordeaux
Summary
Prospective, monocentric study evaluating the presence of sarcopenia prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management.
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.
Source: ClinicalTrials.gov (NCT05415527). StuddyBuddy aggregates publicly available trial information.