UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000478 |
|---|---|
| Receipt number | R000000578 |
| Scientific Title | Preventive effect of frozen glove for docetaxel-induced nail toxicities in advanced breast cancer patients |
| Date of disclosure of the study information | 2006/09/11 |
| Last modified on | 2016/02/24 16:13:05 |
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Basic information
Public title
Preventive effect of frozen glove for docetaxel-induced nail toxicities in advanced breast cancer patients
Acronym
Effect of frozen glove for prevention of docetaxel-induced nail toxicities
Scientific Title
Preventive effect of frozen glove for docetaxel-induced nail toxicities in advanced breast cancer patients
Scientific Title:Acronym
Effect of frozen glove for prevention of docetaxel-induced nail toxicities
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analysis of preventive effect of frozen glove for Docetaxel-induced nail toxicities when used as standard method (frozen @-30C for longer than 3 hours, apply 15 minutes prior to docetaxel infusion and change to new glove after 45 minutes) versus simpler method for advanced breast cancer patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Occurrence of any nail toxicities at 4 months of Docetaxel infusion
Key secondary outcomes
Occurrence of any grade 2 or higher nail toxicities at 4 months of Docetaxel infusion
Time (and total number or amount of Docetaxel administration) until first occurrence of any Docetaxel-induced nail toxicities
Detail classification of grade 2 or higher nail toxicities
Degree of un-comfort by the use of frozen glove
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Simpler freezing method and shorter administration of frozen glove in experimental side (hand)
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
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
Female with pathologically proven breast cancer
Clinical stage 4(TNM) or incurable recurrent breast cancer
PS(ECOG) 0~2
Docetaxel administration 40mg/m2 planed at least more than once a month (before 1st administration)
Preserved major organ function
Written informed consent
Key exclusion criteria
Infection, Fever = or > 38C
Serious comorbidity
Interstitial pneumonitis/fibrosis
Peripheral neuropathy/edema
Raynaud symptom/peripheral arterial disease
Finger skin/bone/soft tissue metastasis
Positive HBsAg
Apparent nail adverse effect
Decision by primary physician
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ishiguro, MD, PhD |
Organization
Kyoto University Hospital
Division name
Outpatient Oncology Unit
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan 606-8507
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Hospital
Division name
Outpatient Oncology Unit
Zip code
Address
TEL
Homepage URL
oncolctr@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Outpatient Oncology Unit
Kyoto University Hospital
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
C79
Org. issuing International ID_1
Kyoto University, Ethical Review Board
Study ID_2
TCO-0604
Org. issuing International ID_2
Kyoto University Hospital, Outpatient Oncology Unit
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 09 | Month | 11 | 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
| 2006 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 08 | Month | 28 | Day |
Last modified on
| 2016 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000578
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