UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033981
Receipt number R000022257
Scientific Title Dexamethasone for the prophylaxis of radiation-induced pain flare after palliative radiotherapy for bone metastases:a phase 2 study.
Date of disclosure of the study information 2018/09/01
Last modified on 2018/09/01 10:04:08

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Basic information

Public title

Dexamethasone for the prophylaxis of radiation-induced pain flare after palliative radiotherapy for bone metastases:a phase 2 study.

Acronym

Dexamethasone for the prophylaxis of pain flare after radiotherapy for bone metastases

Scientific Title

Dexamethasone for the prophylaxis of radiation-induced pain flare after palliative radiotherapy for bone metastases:a phase 2 study.

Scientific Title:Acronym

Dexamethasone for the prophylaxis of pain flare after radiotherapy for bone metastases

Region

Japan


Condition

Condition

bone metastases

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Determing the usufullness of dexamethasone for the prophylaxis of radiation-induced pain flare after palliative radiotherapy for bone metastases

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Investigating of the change of pain after taking of dexamethasone.

Key secondary outcomes



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

dexamethasone

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

10 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

The patient who gave written informed concent.

Key exclusion criteria

The patient who do not informed concent

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Tanaka

Organization

Gifu Municipal Hospital

Division name

Radiation Oncology

Zip code


Address

7-1 Kashima-cho Gifu

TEL

81-58-251-1101

Email

osa0508@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Tanaka

Organization

Gifu Municipal Hospital

Division name

Radiation Oncology

Zip code


Address

7-1 Kashima-cho Gifu

TEL

81-58-251-1101

Homepage URL


Email

osa0508@yahoo.co.jp


Sponsor or person

Institute

Gifu Municipal Hospital

Institute

Department

Personal name



Funding Source

Organization

Gifu Municipal Hospital

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


Address


Tel


Email



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 09 Month 01 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

Completed

Date of protocol fixation

2015 Year 07 Month 28 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 01 Day

Last modified on

2018 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022257


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name