UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017815
Receipt number 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 09:11:30

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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 or person

Institute

Nagoya City University Hospital,Division of Chemotherapy

Institute

Department

Personal name



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

Value
https://center6.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