UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of the preventive effect for vincristin-induced peripheral neuropathy by frozen gloves and socks
Title of the study (Brief title)	Verification of the preventive effect for vincristin-induced peripheral neuropathy by frozen gloves and socks
Region	Japan

Condition
Condition	Cancer
Classification by specialty	Hematology and clinical oncology Orthopedics Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To study the efficacy to prevent vincristin-induced peripheral neuropathy by frozen gloves and socks
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of chemotherapy-induced peripheral neuropathy assessed at each cycle
Key secondary outcomes	FACT/GOG-NTx(patient questionnaire) Tolerability of frozen gloves and socks Skin toxicity

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	All patients wear frozen glove and socks on either side of hand and foot.
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Diagnosed as histologically malignant lymphoma receiving (R-) CHOP therapy or (R-) CVP therapy (vincristin administration). 2) Diagnosed as histologically Ewing sarcoma receiving VDC therapy or VAC therapy (vincristin administration). 3) Diagnosed as histologically rhabdomyosarcoma receiving radiation therapy combination VAC (2200) or VAC (1200) therapy or radiation 4) Patients planned to receive chemotherapy in the age over 15 years old of hospitalization or outpatient chemotherapy room. 5) Cases to have agreed to enter this study as participants from the description document.
Key exclusion criteria	1) Drug allergy that might interfere with this drug, patients with cold allergy and its history. 2)Patients with any of the grade two or more of peripheral neuropathy or limb edema in the registration time. 3)Patients with metastatic tumor found in (sub)cutaneous lesion. 4) Patients with Raynaud's symptoms, peripheral arterial ischemia symptoms, hand-foot syndrome, or injury in the hands or feet, and patients the doctor has determined inadequate for this study. 5) Patients with demyelinating Charcot-Marie-Tooth disease. 6) Patients with pregnancy or breast-feeding.
Target sample size	10

Research contact person
Name of lead principal investigator	Hirokazu Komatsu
Organization	Nagoya City University Hospital
Division name	Division of Chemotherapy
Address	1-Kawasumi, Mizuho-cho,Mizuho-ku, Nagoya
TEL	052-851-5511
Email	komatsu@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Mayumi Haruta
Organization	Nagoya City University Hospital
Division name	Division of Chemotherapy
Address	1-Kawasumi, Mizuho-cho,Mizuho-ku, Nagoya
TEL	052-851-5511(7428)
Homepage URL
Email	kbkyw108@ybb.ne.jp

Sponsor
Institute	Nagoya City University Hospital,Division of Chemotherapy
Institute
Department

Funding Source
Organization	Kidani Memorial Trust
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Aichi Nursing Association

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	名古屋市立大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 08 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 04 Month 02 Day
Anticipated trial start date	2015 Year 06 Month 08 Day
Last follow-up date	2017 Year 12 Month 01 Day
Date of closure to data entry	2017 Year 12 Month 01 Day
Date trial data considered complete	2017 Year 12 Month 01 Day
Date analysis concluded	2017 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 04 Day
Last modified on	2018 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020603