UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027944 |
|---|---|
| Receipt number | R000032007 |
| Scientific Title | Assessment of preventative use of surgical glove for PTX induced peripheral neuropathy |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2025/01/14 16:05:01 |
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Basic information
Public title
Assessment of preventative use of surgical glove for PTX induced peripheral neuropathy
Acronym
Assessment of preventative use of surgical glove for PTX induced peripheral neuropathy
Scientific Title
Assessment of preventative use of surgical glove for PTX induced peripheral neuropathy
Scientific Title:Acronym
Assessment of preventative use of surgical glove for PTX induced peripheral neuropathy
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
There is no established method for prevention of chemotherapy induced peripheral neuropathy(CIPN). In this study, we assess the effectiveness of compression therapy using surgical gloves(SG) for prevention of CIPN.To put it concretely, we assess the difference of occurrence rates of CIPN by the following method; in each patient, 2 SG that are one size smaller than the size that fit are worn on one hand(compression therapy side;CT side),2 SG that fit the patient's glove size are worn on the other hand(control side)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference in the frequency of occurrence of CIPN (motor/sensory) between the CT side hand and the control side hand was determined by the physician in charge using the Common Terminology Criteria for Adverse Events scale version 4.0 (CTCAE v4.0). Grade 2 or more were considered to be CIPN.
Key secondary outcomes
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
For every PTX infusion, each patient wore the 2 smaller SG on one hand (compression therapy side; CT side), and the 2 SG that fit on the other hand (control side) for 90 minutes: the 30 minutes before the administration of PTX, the 30 minutes of PTX infusion itself, and the 30 minutes after the end of the infusion. CT side and control side are blind for both patients and physicians.
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
Female
Key inclusion criteria
1.Who started chemotherapy of wPTX 80mg/m2(plusminus Trastuzumab or Bevacizumab or Pertuzumab plusminus Trastuzumab)
2.ECOG performance status 0 or 1
3.Adequate bone marrow,heart,liver and renal function
4.Informed consent is obtainable from the subject herself in documented form using the Consent Form
Key exclusion criteria
1.Already have peripheral neuropathy >grade 1 by CTCAE v4.0
2.Previous chemotherapy treatment of PTX or nab-PTX
3.The patients whose peripheral intravenous injection is possible only in the area where the gloves are worn
4.History of Raynaud syndrome, hepatitis or other active infectious disease and uncontrolled diabetes
5.Any condition for contraindication of chemotherapy
6.Multiple active cancers (homochromous multiple cancers, or heterochromous multiple cancers with a cancer-free period of less than 5 years prior to randomization)
Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer
7.Active brain metastasis which require immediate medical procedure or radiation therapy
8.Pleural effusion, ascites or pericardial effusion which require immediate medical procedure
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruru Kotani |
Organization
Aichi Cancer Center
Division name
Department of Breast Oncology
Zip code
Address
1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
TEL
052-762-6111
k.haruru@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruru Kotani |
Organization
Aichi Cancer Center
Division name
Department of Breast Oncology
Zip code
Address
1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
TEL
052-762-6111
Homepage URL
k.haruru@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center
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
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
愛知県がんセンター中央病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 26 | 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 | 05 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2017 | Year | 06 | Month | 26 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032007
