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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034966
Receipt No. 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 2019/05/23

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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
Email 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
Email shigematu1330@yahoo.co.jp

Sponsor
Institute National hospital organization KURE medical center
Institute
Department

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
Email 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 No longer recruiting
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 01 Month 01 Day
Date analysis concluded
2020 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2018 Year 11 Month 21 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029607

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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