UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030536 |
|---|---|
| Receipt number | R000034856 |
| Scientific Title | A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients. |
| Date of disclosure of the study information | 2017/12/24 |
| Last modified on | 2019/12/25 02:16:31 |
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Basic information
Public title
A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients.
Acronym
Prophylactic efficacy of frozen gloves or surgical gloves on nab-paclitaxel induced peripheral neuropathy.
Scientific Title
A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients.
Scientific Title:Acronym
Prophylactic efficacy of frozen gloves or surgical gloves on nab-paclitaxel induced peripheral neuropathy.
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of the prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nanoparticle albumin-bound(nab)-paclitaxel-induced peripheral neuropathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The incidence of grade 2 or higher nab-paclitaxel-induced peripheral neuropathy.
Comparison of prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nab-paclitaxel-induced peripheral neuropathy.
Key secondary outcomes
1.Comparison of prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nab-paclitaxel-induced peripheral neuropathy with historical control.
2.Withdrawal of intervention procedures
3.Adverse events of interventional procedures
4.Factors affecting nab-paclitaxel-induced peripheral neuropathy (clinical background, administration of analgesic adjuvant, involvement of dominant hand, etc.)
5.The evaluation of nab-paclitaxel-induced peripheral neuropathy by using the Patient Neurotoxicity Questionnaire and Functional Assessment of Cancer Therapy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
During chemotherapy, wear a frozen glove on one hand and a surgical glove on the other hand continuously, as for frozen glove from 15 minutes before the start of administration of nab-PTX until 15 minutes after the end of the infusion (60 minutes), as for surgical glove from 30 minutes before the start of administration of nab-PTX until 30 minutes after the end of the infusion (90 minutes).
For hands wearing frozen gloves or surgical gloves, "dominant hand" is assigned randomly as the allocation factor.
Interventions/Control_2
Using the thermography, the fingertip
temperature of both hands before and after wearing the glove was measured.
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
Female
Key inclusion criteria
Women with pathologically proven primary or recurrent breast cancer, 20 years of age and older
No peripheral sensory/motor neuropathy or Grade 1 peripheral sensory/motor neuropathy without left/right differences
Patients who can answer Japanese questionnaire without assistance
With written informed consent
Key exclusion criteria
With allergy for material of frozen globe and surgical glove
Patients with neuropathic pain due to diseases such as diabetes and herpes zoster
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Yuko Kanbayashi |
| Middle name | |
| Last name | Kanbayashi |
Organization
Kyoto Prefectural University of Medicine
Division name
Outpatient Oncology Unit
Zip code
602-8566
Address
Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5111
ykokanba@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Kanbayashi |
Organization
Kyoto Prefectural University of Medicine
Division name
Outpatient Oncology Unit
Zip code
602-8566
Address
Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5111
Homepage URL
ykokanba@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Outpatient Oncology Unit, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
京都府立医科大学附属病院（京都府）
Kyoto Prefectural University of Medicine Hospital(Kyoto)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 24 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 23 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034856
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