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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.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