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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name