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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036329
Receipt No. 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 2019/03/21

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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
Email 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
Email info@kyoto-breast-cancer.org

Sponsor
Institute KBCRN Study Office
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 13 Day
Date of IRB
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
2019 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041302

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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