Effects of Glucocorticoid Use during Chemotherapy on Bone Mineral Density and Glucose Tolerance in Patients with Gynecological Cancer: A Prospective Study

UMIN ID: UMIN000055596

Registered date:24/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Uterine corpus cancer and ovarian cancer
• Date of first enrollment: 2024/09/18
• Target sample size: 55
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Dexamethasone sodium phosphate: Administer 13.2 mg via intravenous infusion on the first day of chemotherapy. Dexamethasone: Administer 4 mg orally twice a day (8 mg per day). Administer orally for 3 days, starting from the second day of chemotherapy.
No treatment

Outcome(s)

• Primary Outcome: To investigate changes in bone mineral density (measured using DEXA) and glucose tolerance before and after chemotherapy.
• Secondary Outcome: 1) To investigate changes in bone metabolism markers (serum NTX, BAP, and TRACP5b) before and after chemotherapy. 2) To investigate changes in glucose tolerance (HOMA-R) before and after chemotherapy. For patients taking medications for diabetes, changes in these medications before and after chemotherapy will be examined. 3) To investigate the association between total steroid dose and changes in bone density and glucose tolerance.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 1) Patients with diabetes mellitus requiring insulin treatment. 2) Patients taking medications for osteoporosis. 3) Patients with confirmed osteoporosis requiring treatment. 4) Patients with a young adult mean (YAM) value of 70% or less. 5) Patients with mental disorders or dementia. 6) Patients with any contraindication to dexamethasone treatment. 7) Patients deemed inappropriate for participation in the present study by the principal investigator or co-investigators.

Related Information

• Primary Sponsor: Dokkyo Medical University
• Source(s) of Monetary Support: None