Unique ID issued by UMIN | UMIN000033205 |
---|---|
Receipt number | R000037862 |
Scientific Title | Effects of glucocorticoid used during chemotherapy on bone metabolism and glucose tolerance in patients with endometrial cancer |
Date of disclosure of the study information | 2018/06/30 |
Last modified on | 2022/10/07 10:08:11 |
Effects of glucocorticoid used during chemotherapy on bone metabolism and glucose tolerance in patients with endometrial cancer
Effects of glucocorticoid used during chemotherapy on bone metabolism and glucose tolerance in patients with endometrial cancer
Effects of glucocorticoid used during chemotherapy on bone metabolism and glucose tolerance in patients with endometrial cancer
Effects of glucocorticoid used during chemotherapy on bone metabolism and glucose tolerance in patients with endometrial cancer
Japan |
Endometrial cancer
Obstetrics and Gynecology |
Malignancy
NO
The aim of this study was to evaluate the effect the glucocorticoid dexamethasone administered during chemotherapy as a premedication to prevent nausea, bone metabolism, and glucose tolerance in postoperative endometrial cancer patients.
Safety
Exploratory
To investigate the bone mineral density (BMD) variation in the lumbar vertebrae and femoral neck measured by dual energy x-ray absorptiometry.
The change in serum bone turnover markers (NTX, BAP and TRACP5b) between pre-chemotherapy and post-chemotherapy treatment.
The change in glucose tolerance and insulin resistance (HOMA-R) between pre-chemotherapy and post-chemotherapy treatment.
The correlation between the total amount of glucocorticoids and the change in BMD or glucose tolerance.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Patient receive a dose of oral dexamethasone (4 mg twice daily) from day 2 to 5 of each cycle of chemotherapy.
Patient receive 16.5 mg of dexamethasone intravenously on day 1 of each week.
Dose of dexamethasone reduce to 13.2mg when aprepitant is administered orally at doses of 125 mg on day 1 and 80 mg on days 2 and 3 of each treatment week,
20 | years-old | <= |
75 | years-old | >= |
Female
1. Patients aged between 20 and 75 years.
2. Patients with an Eastern Cooperative Oncology Group Performance status score 0-1.
3. Postoperative endometrial cancer patients who require chemotherapy treatment with dexamethasone.
4. Patients who have not received rdaiotherapy treatment to their pelvic region.
5. Patients who provided written informed consent.
1. Patients with diabetes mellitus who required insulin.
2. Patients who were already taking dexamethasone for osteoporosis.
3. Patients with newly diagnosed osteoporosis requiring medication.
4. T-Score: 2.5 SD or more below the young adult mean (-2.5 SD or lower).
5. Patients with a mental illness or dementia.
6. Patients with any contraindication to dexamethasone treatment.
7. Patients determined to be ineligible by the physician in charge for any other reason.
40
1st name | AKIRA |
Middle name | |
Last name | Mitsuhashi |
Chiba University Hospital
Gynecology
260-8670
1-8-1 Inohana Chuo-ku Chiba Japan
043-222-7171
antira@faculty.chiba-u.jp
1st name | AKIRA |
Middle name | |
Last name | Mitsuhashi |
Chiba University Hospital
Gynecology
260-8670
1-8-1 Inohana Chuo-ku Chiba Japan
043-222-7171
antira@faculty.chiba-u.jp
Chiba University
none
Self funding
Chiba University Hospital Institutional Review Board
1-8-1 Inohana Chuo-ku Chiba Japan
043-222-7171
hanaoka.hideki@faculty.chiba-u.jp
NO
2018 | Year | 06 | Month | 30 | Day |
Unpublished
38
Delay expected |
Data analysis in progress
Completed
2018 | Year | 05 | Month | 01 | Day |
2018 | Year | 05 | Month | 23 | Day |
2018 | Year | 07 | Month | 01 | Day |
2021 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 05 | Month | 09 | Day |
2022 | Year | 09 | Month | 30 | Day |
2018 | Year | 06 | Month | 29 | Day |
2022 | Year | 10 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037862
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |