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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033205
Receipt No. 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 2019/11/03

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Basic information
Public title Effects of glucocorticoid used during chemotherapy on bone metabolism and glucose tolerance in patients with endometrial cancer
Acronym Effects of glucocorticoid used during chemotherapy on bone metabolism and glucose tolerance in patients with endometrial cancer
Scientific Title Effects of glucocorticoid used during chemotherapy on bone metabolism and glucose tolerance in patients with endometrial cancer
Scientific Title:Acronym Effects of glucocorticoid used during chemotherapy on bone metabolism and glucose tolerance in patients with endometrial cancer
Region
Japan

Condition
Condition Endometrial cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the bone mineral density (BMD) variation in the lumbar vertebrae and femoral neck measured by dual energy x-ray absorptiometry.
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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,
Interventions/Control_2
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 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.
Key exclusion criteria 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name AKIRA
Middle name
Last name Mitsuhashi
Organization Chiba University Hospital
Division name Gynecology
Zip code 260-8670
Address 1-8-1 Inohana Chuo-ku Chiba Japan
TEL 043-222-7171
Email antira@faculty.chiba-u.jp

Public contact
Name of contact person
1st name AKIRA
Middle name
Last name Mitsuhashi
Organization Chiba University Hospital
Division name Gynecology
Zip code 260-8670
Address 1-8-1 Inohana Chuo-ku Chiba Japan
TEL 043-222-7171
Homepage URL
Email antira@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba University Hospital Institutional Review Board
Address 1-8-1 Inohana Chuo-ku Chiba Japan
Tel 043-222-7171
Email hanaoka.hideki@faculty.chiba-u.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

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 30 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
2018 Year 05 Month 01 Day
Date of IRB
2018 Year 05 Month 23 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2021 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
2018 Year 06 Month 29 Day
Last modified on
2019 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.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


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