UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000002030
Receipt number	R000002476
Scientific Title	Randomized controlled trial comparing skin-moisturizing agents plus pyridoxine hydrochloride with skin-moisturizing agents alone to prevent hand-foot syndrome in patients received chemotherapy of capecitabine.
Date of disclosure of the study information	2009/06/16
Last modified on	2010/11/30 11:19:16

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Basic information

Public title

Randomized controlled trial comparing skin-moisturizing agents plus pyridoxine hydrochloride with skin-moisturizing agents alone to prevent hand-foot syndrome in patients received chemotherapy of capecitabine.

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Breast Cancer

Classification by specialty

Hematology and clinical oncology Breast surgery Not applicable

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To evaluate the efficacy of applying skin-moisturizing agents alone five times daily as compared to skin-moisturizing agents plus pyridoxine hydrochloride(V.B6).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Percentage of patients with Grade->2 hand-foot sydrome

Key secondary outcomes

Time to the Onset of Grade=>2 hand-foot syndrome
Percentage of patients with Grade=1 hand-foot syndrome

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

skin-moisturizing agents
Grade0-1:heparinoid-containing soft ointment (w/o type)
Grade=>1:heparinoid-containing soft ointment (w/o type)
or
10% urea-containing soft ointment
(w/o type)
Patients receive skin-moisturizing agents applied to palms and soles
5 times daily.

Interventions/Control_2

pyridoxine hydrochloride

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

Not applicable

Gender

Female

Key inclusion criteria

1) Age: At least 20 years of age
2) Patients with recurrent and advanced breast cancer
3) ECOG performance status:0-1
4) Patients without severe dysfunction of major organs
a) T-Bil <=1.5mg/dl
b) AST(GOT)/ALT(GPT) <=100IU/l
c) Patients with liver metastatis:AST(GOT)/ALT(GPT) <=200U/l
d) creatinine clearance =>50ml/min
5) Patients must have signed informed concent

Key exclusion criteria

1) Patients with pervious hypersensitive reactions to component
2) regular use
of pyridoxine hydrochloride
3)Regular use of levodopa
4) Patients with Grade 1 or higher hand-foot syndrome
5) Patients received chemotherapy including 5Fu
6) Patients judged as the exclusive case by the investigator

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Kazuo Komatsubara

Organization

Shikoku Cancer Center

Division name

Department of Hospital Pharmacy

Zip code

Address

160,Minamiumemoto-machi-kou,Ehime

TEL

089-999-1111

Email

Public contact

Name of contact person

1st name

Middle name

Last name Kazuo Komatsubara

Organization

Shikoku Cancer Center

Division name

Department of Hospital Pharmacy

Zip code

Address

160,Minamiumemoto-machi-kou,Ehime

TEL

089-999-1111

Homepage URL

Email

Sponsor or person

Institute

Shikoku Cancer Center

Institute

Department

Personal name

Funding Source

Organization

Policy-Based Medical Survices Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2009 Year 06 Month 16 Day

Related information

URL releasing protocol

Publication of results

Published

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

2009 Year 05 Month 14 Day

Date of IRB

Anticipated trial start date

2009 Year 10 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

2009 Year 06 Month 02 Day

Last modified on

2010 Year 11 Month 30 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002476

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name