UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055596 |
|---|---|
| Receipt number | R000063433 |
| Scientific Title | Effects of Glucocorticoid Use during Chemotherapy on Bone Mineral Density and Glucose Tolerance in Patients with Gynecological Cancer: A Prospective Study |
| Date of disclosure of the study information | 2024/09/24 |
| Last modified on | 2024/09/24 07:44:38 |
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Basic information
Public title
Effects of Glucocorticoid Use during Chemotherapy on Bone Mineral Density and Glucose Tolerance in Patients with Gynecological Cancer: A Prospective Study
Acronym
Effects of glucocorticoids during chemotherapy on bone mineral density and glucose tolerance in patients with gynecological cancer
Scientific Title
Effects of Glucocorticoid Use during Chemotherapy on Bone Mineral Density and Glucose Tolerance in Patients with Gynecological Cancer: A Prospective Study
Scientific Title:Acronym
Effects of glucocorticoids during chemotherapy on bone mineral density and glucose tolerance in patients with gynecological cancer
Region
| Japan |
Condition
Condition
Uterine corpus cancer and ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of glucocorticoids, which are used for allergy prevention and antiemetic purposes during chemotherapy, on bone mineral density and glucose tolerance.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate changes in bone mineral density (measured using DEXA) and glucose tolerance before and after chemotherapy.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
No treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key 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.
Key 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.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Yoshimasa |
| Middle name | |
| Last name | KAWARAI |
Organization
Dokkyo Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
3210293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, JAPAN
TEL
+81-282-86-1111
y-kawarai@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | KAWARAI |
Organization
Dokkyo Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
3210293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, JAPAN
TEL
+81-282-86-1111
Homepage URL
y-kawarai@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Dokkyo Medical University Hospital
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, JAPAN
Tel
+81-282-87-2275
r-kenkyu@dokkyomed.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
獨協医科大学病院 (栃木県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 24 | Day |
Last modified on
| 2024 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063433
