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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002476
