UMIN-CTR Clinical Trial

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

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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

Obstetrics 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 or person

Institute

Chiba University

Institute

Department

Personal name



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

38

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Data analysis in progress

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

Completed

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

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 05 Month 09 Day

Date analysis concluded

2022 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2018 Year 06 Month 29 Day

Last modified on

2022 Year 10 Month 07 Day



Link to view the page

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