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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002030
Receipt No. 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

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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 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.
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.
Scientific Title:Acronym 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.
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Hematology and clinical oncology Breast surgery Not applicable
Classification by malignancy Malignancy
Genomic information NO

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 2
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 20

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
Institute Shikoku Cancer Center
Institute
Department

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
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
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
URL(English) https://upload.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


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