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
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
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
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
