UMIN-CTR Clinical Trial

Basic information
Public title	A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients.
Acronym	Prophylactic efficacy of frozen gloves or surgical gloves on nab-paclitaxel induced peripheral neuropathy.
Scientific Title	A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients.
Scientific Title:Acronym	Prophylactic efficacy of frozen gloves or surgical gloves on nab-paclitaxel induced peripheral neuropathy.
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	To evaluate of the prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nanoparticle albumin-bound(nab)-paclitaxel-induced peripheral neuropathy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The incidence of grade 2 or higher nab-paclitaxel-induced peripheral neuropathy. Comparison of prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nab-paclitaxel-induced peripheral neuropathy.
Key secondary outcomes	1.Comparison of prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nab-paclitaxel-induced peripheral neuropathy with historical control. 2.Withdrawal of intervention procedures 3.Adverse events of interventional procedures 4.Factors affecting nab-paclitaxel-induced peripheral neuropathy (clinical background, administration of analgesic adjuvant, involvement of dominant hand, etc.) 5.The evaluation of nab-paclitaxel-induced peripheral neuropathy by using the Patient Neurotoxicity Questionnaire and Functional Assessment of Cancer Therapy.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	During chemotherapy, wear a frozen glove on one hand and a surgical glove on the other hand continuously, as for frozen glove from 15 minutes before the start of administration of nab-PTX until 15 minutes after the end of the infusion (60 minutes), as for surgical glove from 30 minutes before the start of administration of nab-PTX until 30 minutes after the end of the infusion (90 minutes). For hands wearing frozen gloves or surgical gloves, "dominant hand" is assigned randomly as the allocation factor.
Interventions/Control_2	Using the thermography, the fingertip temperature of both hands before and after wearing the glove was measured.
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	Not applicable
Gender	Female
Key inclusion criteria	Women with pathologically proven primary or recurrent breast cancer, 20 years of age and older No peripheral sensory/motor neuropathy or Grade 1 peripheral sensory/motor neuropathy without left/right differences Patients who can answer Japanese questionnaire without assistance With written informed consent
Key exclusion criteria	With allergy for material of frozen globe and surgical glove Patients with neuropathic pain due to diseases such as diabetes and herpes zoster
Target sample size	34

Research contact person
Name of lead principal investigator	1st name Yuko Kanbayashi Middle name Last name Kanbayashi
Organization	Kyoto Prefectural University of Medicine
Division name	Outpatient Oncology Unit
Zip code	602-8566
Address	Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5111
Email	ykokanba@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Yuko Middle name Last name Kanbayashi
Organization	Kyoto Prefectural University of Medicine
Division name	Outpatient Oncology Unit
Zip code	602-8566
Address	Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5111
Homepage URL
Email	ykokanba@koto.kpu-m.ac.jp

Sponsor
Institute	Department of Outpatient Oncology Unit, Kyoto Prefectural University of Medicine
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	Kyoto Prefectural University of Medicine
Address	Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel	075-251-5337
Email	rinri@koto.kpu-m.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	京都府立医科大学附属病院（京都府） Kyoto Prefectural University of Medicine Hospital(Kyoto)

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 24 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	Completed
Date of protocol fixation	2017 Year 07 Month 11 Day
Date of IRB	2017 Year 07 Month 25 Day
Anticipated trial start date	2017 Year 08 Month 29 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	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 12 Month 23 Day
Last modified on	2019 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034856