UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036329 |
|---|---|
| Receipt number | R000041302 |
| Scientific Title | Multicenter randomized trial to evaluate the efficacy of compression therapy with Elastic Compression Gloves and Stockings for prevention of chemotherapy-induced neuropathy in breast cancer patients |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2020/08/25 14:47:30 |
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Basic information
Public title
Multicenter randomized trial to evaluate the efficacy of compression therapy with Elastic Compression Gloves and Stockings for prevention of chemotherapy-induced neuropathy in breast cancer patients
Acronym
RCT of compression therapy with ECGS for prevention of CIPN
Scientific Title
Multicenter randomized trial to evaluate the efficacy of compression therapy with Elastic Compression Gloves and Stockings for prevention of chemotherapy-induced neuropathy in breast cancer patients
Scientific Title:Acronym
RCT of compression therapy with ECGS for prevention of CIPN
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluate the efficacy of compression therapy with Elastic Compression Gloves and Stockings for prevention of chemotherapy-induced neuropathy in breast cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
1)Score of hands in Patient Neurotoxicity Questionnaire (PNQ) until 12cycle Day8
2)CTCAE grade of hands in until 12cycle Day8
3)Score of feet in Patient Neurotoxicity Questionnaire (PNQ) until 12cycle Day8
4)CTCAE grade of feet in until 12cycle Day8
Key secondary outcomes
1)Time to PNQ score D
2)Time to CTCAE grade 2
3)Grooved pegboard test
4) Semmes-Weinstein monofilament
Test
5)Skin and subcutaneous tissue disorders (CTCAE grade2)
6)Temperature of hands and feet before and after compression
7)Ratio of cases dropping out
8)CIPN 6,12,18,24months after cycle12
9)Pressure of ECGS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Compression therapy with Elastic Compression Gloves and Stockings(ECGS) to the hand and the foot of intervention side:wearing ECGS to the intervention side in all 12 cycles from 30 minutes before administration of paclitaxel therapy to 30 minutes after administration
Interventions/Control_2
No prevention on the control side
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
Female
Key inclusion criteria
Breast cancer patients planning to receive more than 12cycles of weekly Paclitaxel therapy
Key exclusion criteria
Patients who have CTCAE more than grade1 neuropathy and/or skin disorders
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuko |
| Middle name | |
| Last name | Kawaguchi |
Organization
Kyoto University
Division name
Clinical Oncology
Zip code
6068507
Address
54 Shogoin Kawara-cho Sakyo-ku, Kyoto
TEL
075-751-3660
nobuko75@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Sakamoto |
Organization
General Incorporated Association Kyoto Breast Cancer Research Network
Division name
KBCRN Study Office
Zip code
6018001
Address
1-10 Higashikuzyoumuromachi Minami-ku,Kyoto
TEL
075-585-7861
Homepage URL
info@kyoto-breast-cancer.org
Sponsor or person
Institute
KBCRN Study Office
Institute
Department
Personal name
Funding Source
Organization
Japan Agency of Medical Research and Development(AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Society of Clinical Oncology
IRB Contact (For public release)
Organization
Kyoto University Certified Review Board
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
京都大学医学部附属病院（京都府）
大阪赤十字病院（大阪府）
兵庫県立尼崎総合医療センター（兵庫県）
神戸市立医療センター中央病院（兵庫県）
天理よろづ相談所病院（奈良県）
日本赤十字社和歌山医療センター（和歌山県）
神鋼記念病院（兵庫県）
田附興風会医学研究所北野病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 01 | 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
0
Results
Because we decided to change the plan and conduct the clinical research based on it.
Results date posted
| 2020 | Year | 08 | Month | 25 | Day |
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
Terminated
Date of protocol fixation
| 2019 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 28 | Day |
Last modified on
| 2020 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041302
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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