Evaluating muscle loss in patients with inoperable high-grade ovarian cancer during treatment
Evaluation of Pretreatment Sarcopenia in Patients With Inoperable High-grade Ovarian Carcinoma as Part of Optimised Management
This study is testing how muscle loss affects patients with inoperable high-grade ovarian cancer during their chemotherapy treatment to see how it impacts their health and recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut Bergonié Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05415527 on ClinicalTrials.gov |
What this trial studies
This study evaluates the presence of sarcopenia in patients with inoperable high-grade epithelial ovarian carcinoma before and during neoadjuvant chemotherapy. Patients will undergo assessments at multiple time points, including before treatment, after three cycles of neoadjuvant chemotherapy, after three cycles of adjuvant chemotherapy, and nine months post-surgery. The evaluation will involve CT scans and bone mineral density tests, alongside nutritional monitoring and adapted physical activity to optimize patient management and quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with inoperable high-grade epithelial ovarian carcinoma requiring chemotherapy.
Not a fit: Patients over the age of 70 requiring oncogeriatric surgery or those with contraindications to CT scans or bone mineral densitometry may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for patients with ovarian carcinoma by addressing muscle loss and nutritional needs.
How similar studies have performed: While the evaluation of sarcopenia in cancer patients is gaining attention, this specific approach combining nutritional monitoring and adapted physical activity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bordeaux
- Institut Bergonié — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Jean-Pierre GEKIERE, MD — Institut Bergonié
- Study coordinator: Jean-Pierre GEKIERE, MD
- Email: j.gekiere@bordeaux.unicancer.fr
- Phone: 05 56 33 33 47
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.