UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059735 |
|---|---|
| Receipt number | R000067337 |
| Scientific Title | Effect of treatment with compression gloves/stockings and ice packs to prevent paclitaxel-induced peripheral neuropathy |
| Date of disclosure of the study information | 2025/11/11 |
| Last modified on | 2025/11/11 09:47:49 |
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Basic information
Public title
Effect of treatment with compression gloves/stockings and ice packs to prevent paclitaxel-induced peripheral neuropathy - Phase 2 study
Acronym
Effect of treatment with compression gloves/stockings and ice packs to prevent paclitaxel-induced peripheral neuropathy
Scientific Title
Effect of treatment with compression gloves/stockings and ice packs to prevent paclitaxel-induced peripheral neuropathy
Scientific Title:Acronym
Effect of treatment with compression gloves/stockings and ice packs to prevent paclitaxel-induced peripheral neuropathy
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the preventive effect of compression and cooling of the hands and feet for neuropathy due to paclitaxel
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of Grade 2 or higher peripheral sensory neuropathy in the hands
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
wear two surgical gloves and stockings
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Considered eligible to neoadjuvant or adjuvant weekly paclitaxel therapy (80mg/m2, 12 doses)
2)ECOG performance status 0-1
3)Signed written informed consent
Key exclusion criteria
1)Poorly controlled complication (infection, diabetes mellitus, and others)
2)Severe pleural effusion and ascites
3)Pregnant or possibly pregnant
4)have with Grade 2 or higher peripheral sensory neuropathy (CTCAE ver4.0)
5)received previous taxane chemotherapy
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Yuri |
| Middle name | |
| Last name | Tamura |
Organization
Osaka City General Hospital
Division name
Department of Breast Surgical Oncology
Zip code
534-0021
Address
2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL
06-6929-1221
wbykk742@gmail.com
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Tamura |
Organization
Osaka City General Hospital
Division name
Department of Breast Surgical Oncology
Zip code
534-0021
Address
2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL
06-6929-1221
Homepage URL
wbykk742@gmail.com
Sponsor or person
Institute
Osaka City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka City General Hospital
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
IRB, Osaka City General Hospital
Address
2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
Tel
06-6929-3269
rinshokenkyu@osakacity-hp.or.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
大阪市立総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 11 | Day |
Last modified on
| 2025 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067337
