UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055289 |
|---|---|
| Receipt number | R000063175 |
| Scientific Title | A randomized controlled trial of cooling therapy for preventing chemotherapy-induced peripheral neuropathy |
| Date of disclosure of the study information | 2024/08/20 |
| Last modified on | 2024/08/20 16:53:47 |
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Basic information
Public title
Examination of cooling therapy for preventing chemotherapy-induced peripheral neuropathy
Acronym
Examination of cooling therapy for preventing chemotherapy-induced peripheral neuropathy
Scientific Title
A randomized controlled trial of cooling therapy for preventing chemotherapy-induced peripheral neuropathy
Scientific Title:Acronym
A randomized controlled trial of cooling therapy for preventing chemotherapy-induced peripheral neuropathy
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and evaluate the blood flow changes caused by cold therapy using hand cooling and wrist cooling for preventing chemotherapy-induced peripheral neuropathy
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow velocity
Key secondary outcomes
Skin temperature
Subjective evaluation of skin sensation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In the intervention group, the fingers will be cooled for 15 minutes using ice gloves filled with cold packs.
Interventions/Control_2
In the control group, the wrist will be cooled for 15 minutes using ice gloves filled with cold packs
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy adults aged 18 and over
Key exclusion criteria
Those who have peripheral nerve damage in the fingers
Those who have wounds or injuries on the cooling areas
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Misako |
| Middle name | |
| Last name | Dai |
Organization
Ishikawa Prefectural Nursing University
Division name
Faculty of Nursing
Zip code
929-1210
Address
1-1, Gakuendai, Kahoku, Ishiskawa, Japan
TEL
0762818334
misakodai0909@gmail.com
Public contact
Name of contact person
| 1st name | Misako |
| Middle name | |
| Last name | Dai |
Organization
Ishikawa Prefectural Nursing University
Division name
Faculty of Nursing
Zip code
929-1210
Address
1-1, Gakuendai, Kahoku, Ishikawa
TEL
0762818334
Homepage URL
misakodai0909@gmail.com
Sponsor or person
Institute
Ishikawa Prefectural Nursing University
Institute
Department
Personal name
Misako Dai
Funding Source
Organization
Ishikawa Prefectural Nursing University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ishikawa Prefectural Nursing University Ethics Committee
Address
1-1, Gakuendai, Kahoku, Ishikawa
Tel
0762818300
daim000@ishikawa-nu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 20 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063175
