UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016902 |
|---|---|
| Receipt number | R000019370 |
| Scientific Title | Search for preventive effect of frozen gloves and compression stockings for peripheral nerve disorder in breast cancer patients who received preoperative nab-paclitaxel treatment.(SPOT trial) |
| Date of disclosure of the study information | 2015/03/24 |
| Last modified on | 2019/11/26 14:41:28 |
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Basic information
Public title
Search for preventive effect of frozen gloves and compression stockings for peripheral nerve disorder in breast cancer patients who received preoperative nab-paclitaxel treatment.(SPOT trial)
Acronym
SPOT trial
Scientific Title
Search for preventive effect of frozen gloves and compression stockings for peripheral nerve disorder in breast cancer patients who received preoperative nab-paclitaxel treatment.(SPOT trial)
Scientific Title:Acronym
SPOT trial
Region
| Japan |
Condition
Condition
Operable breast cancer
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of frozen globes and elastic stockings for chemotheerapy-induced peripheral neuropathy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence and timing of grade 2 or higher peripheral neuropathy during nab-paclitaxel
Key secondary outcomes
(1)The incidence of grade 2 or higher peripheral neuropathy at the end of nab-paclitaxel
(2)HRQOL
(3)The incidence of peripheral neuropathy at five year after nab-paclitaxel administration
(4)Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Each patients wears frozen globes and elastic stockings on the dominant hand and foot
Interventions/Control_2
no treatment
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Patients are histologically proven breast cancer
(2) Aged 20-70
(3) Scheduled to receive nab-paclitaxel following other chemotherapy
(4) No prior chemotherapy for breast cancer
(5) Performance Status (PS) 0-1
(6) Patients are judged by investigators with adequate organ function within two weeks
neutrophil counts >= 1,500/mm3
platelets >= 10.0*10^4/mm3
hemoglobin >= 10.0g/dL
AST < 100U/L
ALT < 100U/L
T-Bil <= 1.5mg/dL
Creatinine < 1.5mg/dL
(7) Without history or complication of peripheral neuropathy
(8) With written informed consent
Key exclusion criteria
(1) With allergy for material of frozen globe and elastic stocking
(2) Using elastic stocking regularly
(3) With server artery dysfunction and congestive heart failure, just after dermal graft, necrosis, sever edema, suppurative disease on the skin
(4) With extreme leg deformity
(5) Administering medicine for thrombosis
(6) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Kashiwaba |
Organization
Hakuaikai Sagara Hospital
Division name
Department of Breast Surgery
Zip code
892-0833
Address
3-31 Matsubara-cho, Kagoshima, Japan
TEL
099-224-1800
m.kashiwaba@sagara.or.jp
Public contact
Name of contact person
| 1st name | Norikazu |
| Middle name | |
| Last name | Masuda |
Organization
Osaka National Hospital
Division name
Department of Surgery
Zip code
540-0006
Address
2-1-14, Houenzaka, Chuo-ku, Osaka, Japan
TEL
06-6942-1331
Homepage URL
nmasuda@alpha.ocn.ne.jp
Sponsor or person
Institute
The Supporting Center for Clinical Research and Education
Institute
Department
Personal name
Funding Source
Organization
Taiho Pharmaceutical co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakuaikai Sagara Hospital
Address
3-31 Matsubara-cho, Kagoshima, Japan
Tel
099-224-1800
m.kashiwaba@sagara.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
| 2015 | Year | 03 | 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
| 2015 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 24 | Day |
Last modified on
| 2019 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019370
