UMIN-CTR Clinical Trial

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
Email	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
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	Hakuaikai Sagara Hospital
Address	3-31 Matsubara-cho, Kagoshima, Japan
Tel	099-224-1800
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019370