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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016902
Receipt No. 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 2019/09/20

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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
Middle name
Last name Masahiro Kashiwaba
Organization Iwate Medical University
Division name Department of Surgery
Zip code
Address 19-1, Uchimaru, Morioka city, Iwate, Japan
TEL 019-651-5111
Email mkashiwa@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norikazu Masuda
Organization Osaka National Hospital
Division name Department of Surgery
Zip code
Address 2-1-14, Houenzaka, Chuo-ku, Osaka, Japan
TEL 06-6942-1331
Homepage URL
Email nmasuda@alpha.ocn.ne.jp

Sponsor
Institute The Supporting Center for Clinical Research and Education
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2015 Year 01 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
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 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019370

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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