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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013398
Receipt No. R000015629
Scientific Title A study of the efficacy of frozen glove and socks for prevention of chemotherapy-induced peripheral neuropathy
Date of disclosure of the study information 2014/03/11
Last modified on 2018/03/15

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Basic information
Public title A study of the efficacy of frozen glove and socks for prevention of chemotherapy-induced peripheral neuropathy
Acronym Cryotherapy for prevention of peripheral neuropathy
Scientific Title A study of the efficacy of frozen glove and socks for prevention of chemotherapy-induced peripheral neuropathy
Scientific Title:Acronym Cryotherapy for prevention of peripheral neuropathy
Region
Japan

Condition
Condition Cancer
Classification by specialty
Hematology and clinical oncology Breast surgery Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To study the efficacy of frozen glove and socks to prevent chemotherapy induced peripheral neuropathy (CIPN), and search for risk factor of CIPN.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of CIPN(tactile sensation threshold) assessed at each cycle.
Key secondary outcomes Vibration threshold
Threshold of temperature perception
Hand function
Nerve conduction velocity
Somatosensory evoked potential
Current perception threshold
Patient Neurotoxicity Questionnaire
Acute pain
Adverse events and tolerability (CIPN or other events)
Discomfort with cooling
(pain / paresthesia / arthritis / other)
Demand of cryotherapy for both hands

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Patients wear frozen gloves and socks on their dominant hand and foot from the second chemotherapy to the end of it, as the following process.
1. Gloves and socks will be frozen for over 3 hours in less than -30 degrees.
2. Fifteen minutes before the paclitaxel infusion, each patient will wear the frozen glove and sock on his or her dominant side. The non-dominant side acts as an untreated control.
3. After 45 minutes of wearing them, they will be replaced with a new frozen glove and sock.
4. Fifteen minutes after the infusion of paclitaxel, the patient will remove the sock and glove.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Scheduled to receive weekly paclitaxel (at 80mg/m2 via 1-hour infusion) at least 4weeks.
2. 20 years of age or over.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
4. Patients who gave written informed consent.
Key exclusion criteria 1. Peripheral sensory/motor neuropathy, neuralgia or edema of limb which were graded 2 or higher (CTCAE ver4.0)
2. Presence of metastasis in the bone, soft tissue or skin of the hands or foot
3. Patient with finger or toe defect
4. Not suitable for participation with Raynaud's symptoms,peripheral arterial ischemia, hand-foot syndrome, or any other reasons.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadao Tsuboyama
Organization Kyoto university graduate school of medicine
Division name Human Health Science
Zip code
Address 53, Syogoinkawaharacho, Sakyo-ku, Kyoto-shi, Kyoto
TEL 075-751-3948
Email tsubo@hs.med.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Hanai
Organization Kyoto university graduate school of medicine
Division name Human Health Science
Zip code
Address 53, Syogoinkawaharacho, Sakyo-ku, Kyoto-shi, Kyoto
TEL 075-751-3944
Homepage URL
Email hanai.akiko.44w@st.kyoto-u.ac.jp

Sponsor
Institute Kyoto university
Institute
Department

Funding Source
Organization Cancer professional training base promotion plan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Japan Society for the Promotion of Science

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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://academic.oup.com/jnci/article/110/2/141/4443215
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
2013 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 19 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2016 Year 09 Month 18 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 11 Day
Last modified on
2018 Year 03 Month 15 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015629

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2016/09/13 20160801CIPN全データ.xlsx


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