UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013398 |
|---|---|
| Receipt number | 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 13:59:13 |
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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
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
hanai.akiko.44w@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015629
