UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000478
Receipt No. 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

* 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 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
Email

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
Email oncolctr@kuhp.kyoto-u.ac.jp

Sponsor
Institute Outpatient Oncology Unit
Kyoto University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000578

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.