UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000028581