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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017815
Receipt No. R000020603
Scientific Title Verification of the preventive effect for vincristin-induced peripheral neuropathy by frozen gloves and socks
Date of disclosure of the study information 2015/06/08
Last modified on 2018/12/06

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Basic information
Public title Verification of the preventive effect for vincristin-induced peripheral neuropathy by frozen gloves and socks
Acronym Verification of the preventive effect for vincristin-induced peripheral neuropathy by frozen gloves and socks
Scientific Title Verification of the preventive effect for vincristin-induced peripheral neuropathy by frozen gloves and socks
Scientific Title:Acronym 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
1st name
Middle name
Last name Hirokazu Komatsu
Organization Nagoya City University Hospital
Division name Division of Chemotherapy
Zip code
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
1st name
Middle name
Last name Mayumi Haruta
Organization Nagoya City University Hospital
Division name Division of Chemotherapy
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2014 Year 04 Month 02 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000020603

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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