UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024836 |
|---|---|
| Receipt number | R000028581 |
| Scientific Title | Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy in primary breast cancer patients:a phase 3 multicenter study (single-armed study) |
| Date of disclosure of the study information | 2016/11/14 |
| Last modified on | 2019/05/18 15:39:16 |
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Basic information
Public title
Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy in primary breast cancer patients:a phase 3 multicenter study (single-armed study)
Acronym
Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy:a phase 3 multicenter study
Scientific Title
Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy in primary breast cancer patients:a phase 3 multicenter study (single-armed study)
Scientific Title:Acronym
Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy:a phase 3 multicenter study
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the effect of compression therapy by surgical gloves for prevention of nab-paclitaxel-induced peripheral
neuropathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Occurrence of nab-paclitaxel-induced peripheral neuropathy of grade 2 or higher
Key secondary outcomes
1) The evaluation of nab-paclitaxel-induced PN by using the Patient Neurotoxicity Questionnaire (we call PNQ)
2) The changes in the temperature of each fingertip
3) Withdrawal rate of wearing sutgical gloves
4) Adverse events of wearung surgical gloves
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
wear two surgical gloves of the same size on both hands
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Histologically orcytologically confirmed invasive breast cancer
2) Considered eligible to neoadjuvant
chemotherapy or adjuvant chemotherapy
3)ECOG performance status 0-1
4)No peripheral sensory / motor neuropathy (CTCAE ver4.0)
5)Adequate organ function, Adequate organ function
6)Signed written informed consent
Key exclusion criteria
1)have any peripheral sensory / motor neuropathy (CTCAE ver4.0)
2)received previous chemotherapy
3) Multiple primary cancer. However,
carcinoma in situ can be cured by local
treatment is not included in multiple
primary cancer
4) Synchronous bilateral breast cancer
5) Brain metastasis
6) Poorly controlled complication (infection, diabetes mellitus, and others)
Target sample size
57
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Tsuyuki |
Organization
Osaka Red Cross Hospital
Division name
Department of Breast Surgery
Zip code
543-8555
Address
5-30 Fudegasaki-cho, Tennoji-ku, Osaka, Japan
TEL
06-6774-5111
tyksgr@osaka-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Tsuyuki |
Organization
Osaka Red Cross Hospital
Division name
Department of Breast Surgery
Zip code
543-8555
Address
5-30 Fudegasaki-cho, Tennoji-ku, Osaka, Japan
TEL
06-6774-5111
Homepage URL
tyksgr@osaka-med.jrc.or.jp
Sponsor or person
Institute
Kamigata Breast Cancer Study Group
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
Medical Ethics Review Committee, Osaka Red Cross Hospital
Address
5-30 Fudegasaki-cho, Tennoji-ku, Osaka, Japan
Tel
06-6774-5111
soumuka@osaka-med.jrc.or.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
| 2016 | Year | 11 | Month | 14 | 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
61
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
| 2016 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 15 | 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
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 14 | Day |
Last modified on
| 2019 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028581
