UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014064 |
|---|---|
| Receipt number | R000016374 |
| Scientific Title | A phase II study of the efficacy of Compression therapy by using surgical gloves for prevention of nab-paclitaxel-induced peripheral neuropathy in primary and metastatic breast cancer patients. |
| Date of disclosure of the study information | 2014/05/27 |
| Last modified on | 2016/10/12 12:55:47 |
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Basic information
Public title
A phase II study of the efficacy of Compression therapy by using surgical gloves for prevention of nab-paclitaxel-induced peripheral neuropathy in primary and metastatic breast cancer patients.
Acronym
A phase II study of the efficacy of Compression therapy by using surgical gloves for prevention of nab-paclitaxel-induced peripheral neuropathy in breast cancer patients.
Scientific Title
A phase II study of the efficacy of Compression therapy by using surgical gloves for prevention of nab-paclitaxel-induced peripheral neuropathy in primary and metastatic breast cancer patients.
Scientific Title:Acronym
A phase II study of the efficacy of Compression therapy by using surgical gloves for prevention of nab-paclitaxel-induced peripheral neuropathy in breast cancer patients.
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of Compression therapy by surgical gloves for prevention of nab-paclitaxel-induced peripheral neuropathy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Grade 2=< Sensory/motor peripheral neuropathy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Wear a Surgical glove on the dominant hand
Interventions/Control_2
wear nothing on the non-dominant hand
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 or cytologically confirmed invasive breast cancer.
2)Considered eligible to neoadjuvant chemotherapy, adjuvant chemotherapy, or chemotherapy as recurrence treatment.
3)Age>=20years old=<75 years
4)ECOG performance status 0-1
5)No Peripheral sensory/motor neuropathy (CTCAE ver4.0)
6) Adequate organ function, Adequate organ function within 2 weeks
Leukocyte count >= 4000/mm3
Neutrophil count >= 1500/mm3
Platelet count >= 100000/mm3
Hemoglobin >= 9.0 g/dl
Aspartate aminotransferase level =<ULN x 2.5
Alanine aminotransferase level =<ULN x 2.5
Total bilirubin =< 1.5 mg/dl
Serum creatinine =< 1.2 mg/dl
7) No clinical abnormality by electrocardiography
8) No interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan
9) Signed written informed consent
Key exclusion criteria
1) Multiple primary cancer. However, carcinoma in situ can be cured by local treatment is not included in multiple primary cancer.
2) Synchronous bilateral breast cancer.
3) Poorly controlled complication (infection, diabetes mellitus, and others).
4) Hypersensitivity to any agents necessary in the planned treatment.
5) Positive for HBs antigen.
6) Previous history of serious heart or lung disease
7) Peripheral sensory/motor neuropathy
8) Transfusion within 2 years
9) Previous history or receiving treatment of dementia or serious psychiatric disorder.
10) Large pleural effusion or ascites
11) Women who are pregnant, lactating or with childbearing potential.
12) Ineligible based on decision of an investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Tsuyuki |
Organization
Osaka Red Cross Hospital
Division name
Breast Surgery
Zip code
Address
5-30,Fudegasaki-cho,Tennoji-ku,Osaka
TEL
06-6774-5111
tyksgr@osaka-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Tsuyuki |
Organization
Osaka Red Cross Hospital
Division name
Breast Surgery
Zip code
Address
5-30,Fudegasaki-cho,Tennoji-ku,Osaka
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
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://link.springer.com/journal/10549
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 | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 25 | Day |
Last modified on
| 2016 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016374
