UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034966 |
|---|---|
| Receipt number | R000029607 |
| Scientific Title | Randomized study of frozen gloves/socks for the prevention of paclitaxel-induced neuropathy in breast cancer patients |
| Date of disclosure of the study information | 2018/11/21 |
| Last modified on | 2019/11/22 13:01:08 |
* 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 study of frozen gloves/socks for the prevention of paclitaxel-induced neuropathy in breast cancer patients
Acronym
Evaluation of frozen gloves/socks for the prevention of paclitaxel-induced neuropathy
Scientific Title
Randomized study of frozen gloves/socks for the prevention of paclitaxel-induced neuropathy in breast cancer patients
Scientific Title:Acronym
Evaluation of frozen gloves/socks for the prevention of paclitaxel-induced neuropathy
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of frozen gloves/socks for the prevention of paclitaxel-induced neuropathy in breast cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
FACT-NTX(Functional Assessment of Cancer Therapy-neurotoxicity) score
Key secondary outcomes
FACT-Taxane score, PNQ(Patient Neurotoxicity Questionnaire), CTCAE (common terminology criteria for adverse event) for periphereal neuropathy, safety, Evaluation of the temperature of the tip of each hand and foot
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Frozen gloves/socks are frigerated at -20C. With every paclitaxel infusion, each patient wear an frozen gloves/socks for a total of 90 minutes on the both hands and feet (15 minutes before the adminiatration of paclitaxel, during 1 hour paclitaxel infusion, and 15 minutes after the end of infusion).
Interventions/Control_2
standard care
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
pathologically proven invasive breast cancer
planned to receive 4 cycle of weekly paclitaxel treatment
adequate hematologic, hepatic, and renal function
Eastern Cooperative Oncology Group performance status of 0 to 1
providing written informed consent
Key exclusion criteria
peripheral neuropathy grade 2 or higher
receiving any agents that altering peripheral neuropathy
Raynaud's phenomenon
pregnancy or breast feeding
any other reason of no-suitable for registration
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Shigematsu |
Organization
National hospital organization KURE medical center
Division name
Breast surgery
Zip code
737-0023
Address
Aoyama 3-1, Kure city, Hiroshima prefecture, Japan
TEL
0823-22-3111
ozakis@kure-nh.go.jp
Public contact
Name of contact person
| 1st name | Hideo |
| Middle name | |
| Last name | Shigematsu |
Organization
National hospital organization KURE medical center
Division name
Breast surgery
Zip code
737-0023
Address
Aoyama 3-1, Kure city, Hiroshima prefecture, Japan
TEL
0823-22-3111
Homepage URL
shigematu1330@yahoo.co.jp
Sponsor or person
Institute
National hospital organization KURE medical center
Institute
Department
Personal name
Funding Source
Organization
National hospital organization KURE medical center
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National hospital organization KURE medical center
Address
Aoyama 3-1, Kure city, Hiroshima prefecture, Japan
Tel
0823-22-3111
506-chiken@mail.hosp.go.jp
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
| 2018 | Year | 11 | Month | 21 | 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
44
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
| 2017 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 21 | Day |
Last modified on
| 2019 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029607
