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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024836
Receipt No. R000028581
Scientific Title Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy in primary breast cancer patients:a phase 3 multicenter study (single-armed study)
Date of disclosure of the study information 2016/11/14
Last modified on 2019/05/18

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Basic information
Public title Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy in primary breast cancer patients:a phase 3 multicenter study (single-armed study)
Acronym Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy:a phase 3 multicenter study
Scientific Title Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy in primary breast cancer patients:a phase 3 multicenter study (single-armed study)
Scientific Title:Acronym Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy:a phase 3 multicenter study
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The evaluation of the effect of compression therapy by surgical gloves for prevention of nab-paclitaxel-induced peripheral
neuropathy.

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Occurrence of nab-paclitaxel-induced peripheral neuropathy of grade 2 or higher
Key secondary outcomes 1) The evaluation of nab-paclitaxel-induced PN by using the Patient Neurotoxicity Questionnaire (we call PNQ)
2) The changes in the temperature of each fingertip
3) Withdrawal rate of wearing sutgical gloves
4) Adverse events of wearung surgical gloves

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 of the same size on both hands
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
75 years-old >=
Gender Female
Key inclusion criteria 1)Histologically orcytologically confirmed invasive breast cancer
2) Considered eligible to neoadjuvant
chemotherapy or adjuvant chemotherapy
3)ECOG performance status 0-1
4)No peripheral sensory / motor neuropathy (CTCAE ver4.0)
5)Adequate organ function, Adequate organ function
6)Signed written informed consent
Key exclusion criteria 1)have any peripheral sensory / motor neuropathy (CTCAE ver4.0)
2)received previous chemotherapy
3) Multiple primary cancer. However,
carcinoma in situ can be cured by local
treatment is not included in multiple
primary cancer
4) Synchronous bilateral breast cancer
5) Brain metastasis
6) Poorly controlled complication (infection, diabetes mellitus, and others)


Target sample size 57

Research contact person
Name of lead principal investigator
1st name Shigeru
Middle name
Last name Tsuyuki
Organization Osaka Red Cross Hospital
Division name Department of Breast Surgery
Zip code 543-8555
Address 5-30 Fudegasaki-cho, Tennoji-ku, Osaka, Japan
TEL 06-6774-5111
Email tyksgr@osaka-med.jrc.or.jp

Public contact
Name of contact person
1st name Shigeru
Middle name
Last name Tsuyuki
Organization Osaka Red Cross Hospital
Division name Department of Breast Surgery
Zip code 543-8555
Address 5-30 Fudegasaki-cho, Tennoji-ku, Osaka, Japan
TEL 06-6774-5111
Homepage URL
Email tyksgr@osaka-med.jrc.or.jp

Sponsor
Institute Kamigata Breast Cancer Study Group
Institute
Department

Funding Source
Organization none
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 Medical Ethics Review Committee, Osaka Red Cross Hospital
Address 5-30 Fudegasaki-cho, Tennoji-ku, Osaka, Japan
Tel 06-6774-5111
Email soumuka@osaka-med.jrc.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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 14 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 61
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
2016 Year 09 Month 30 Day
Date of IRB
2016 Year 10 Month 01 Day
Anticipated trial start date
2016 Year 10 Month 15 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 14 Day
Last modified on
2019 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028581

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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