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

Effects of Glucocorticoid Use during Chemotherapy on Bone Mineral Density and Glucose Tolerance in Patients with Gynecological Cancer: A Prospective Study - Effects of glucocorticoids during chemotherapy on bone mineral density and glucose tolerance in patients with gynecological cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055596
Enrollment
55
Registered
2024-09-24
Start date
2024-09-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine corpus cancer and ovarian cancer

Interventions

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

Sponsors

Dokkyo Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Patients aged 20 years or older and 75 years or younger. 2) Patients with a Performance Status (ECOG scale) of 0-1. 3) Patients who have not received prior radiation therapy to the pelvic region. 4) Patients who have provided written informed consent of their own free will after receiving a thorough explanation of the study.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
To investigate changes in bone mineral density (measured using DEXA) and glucose tolerance before and after chemotherapy.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactYoshimasa KAWARAI

Dokkyo Medical University Department of Obstetrics and Gynecology

y-kawarai@dokkyomed.ac.jp+81-282-86-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026