UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of the efficacy of Compression therapy by using surgical gloves for prevention of nab-paclitaxel-induced peripheral neuropathy in primary and metastatic breast cancer patients.
Title of the study (Brief title)	A phase II study of the efficacy of Compression therapy by using surgical gloves for prevention of nab-paclitaxel-induced peripheral neuropathy in breast cancer patients.
Region	Japan

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

Objectives
Narrative objectives1	The efficacy of Compression therapy by surgical gloves for prevention of nab-paclitaxel-induced peripheral neuropathy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Grade 2=< Sensory/motor peripheral neuropathy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Wear a Surgical glove on the dominant hand
Interventions/Control_2	wear nothing on the non-dominant hand
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 or cytologically confirmed invasive breast cancer. 2)Considered eligible to neoadjuvant chemotherapy, adjuvant chemotherapy, or chemotherapy as recurrence treatment. 3)Age>=20years old=<75 years 4)ECOG performance status 0-1 5)No Peripheral sensory/motor neuropathy (CTCAE ver4.0) 6) Adequate organ function, Adequate organ function within 2 weeks Leukocyte count >= 4000/mm3 Neutrophil count >= 1500/mm3 Platelet count >= 100000/mm3 Hemoglobin >= 9.0 g/dl Aspartate aminotransferase level =<ULN x 2.5 Alanine aminotransferase level =<ULN x 2.5 Total bilirubin =< 1.5 mg/dl Serum creatinine =< 1.2 mg/dl 7) No clinical abnormality by electrocardiography 8) No interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan 9) Signed written informed consent
Key exclusion criteria	1) Multiple primary cancer. However, carcinoma in situ can be cured by local treatment is not included in multiple primary cancer. 2) Synchronous bilateral breast cancer. 3) Poorly controlled complication (infection, diabetes mellitus, and others). 4) Hypersensitivity to any agents necessary in the planned treatment. 5) Positive for HBs antigen. 6) Previous history of serious heart or lung disease 7) Peripheral sensory/motor neuropathy 8) Transfusion within 2 years 9) Previous history or receiving treatment of dementia or serious psychiatric disorder. 10) Large pleural effusion or ascites 11) Women who are pregnant, lactating or with childbearing potential. 12) Ineligible based on decision of an investigator.
Target sample size	40

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

Public contact
Name of contact person	Shigeru Tsuyuki
Organization	Osaka Red Cross Hospital
Division name	Breast Surgery
Address	5-30,Fudegasaki-cho,Tennoji-ku,Osaka
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)

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	2014 Year 05 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 16 Day
Anticipated trial start date	2013 Year 07 Month 16 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 05 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://link.springer.com/journal/10549
Results
Other related information

Management information
Registered date	2014 Year 05 Month 25 Day
Last modified on	2016 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016374