UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007907
Receipt number R000009259
Scientific Title Evaluation of the efficacy of Frozen Glove to prevent peripheral neuropathy in patients who receive nab-paclitaxel treatment
Date of disclosure of the study information 2012/05/15
Last modified on 2019/11/16 14:05:19

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Basic information

Public title

Evaluation of the efficacy of Frozen Glove to prevent peripheral neuropathy in patients who receive nab-paclitaxel treatment

Acronym

TBCRG05

Scientific Title

Evaluation of the efficacy of Frozen Glove to prevent peripheral neuropathy in patients who receive nab-paclitaxel treatment

Scientific Title:Acronym

TBCRG05

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of Frozen Glove to prevent peripheral neuropathy for patients who receive nab-paclitaxel treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

Comparison of the rates of peripheral sensory neuropathy between protected and control hand. (Equal or more than PNQ Grade 2)

Key secondary outcomes

Percentage of patients who carry nab-paclitaxel through four cycles
Comparison of the rates of peripheral moter neuropathy(PNQ Grade)
Comparison of the rates of peripheral sensory and moter neuropathy(PRO-CTCAE Grade)
Comparison of the rates of peripheral sensory and moter neuropathy(CTCAE v4.0 Grade)
Comparison of quantitative determination of peripheral sensory neuropathy with PAIN VISION


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Frozen Glove attach to the hand and foot of the patients on the diseased side during infusion of nab-paclitaxel.
Control: healthy side

Interventions/Control_2


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

Male and Female

Key inclusion criteria

1.Histologically confirmed primary breast cancer
2.Metastatic or recurrent breast cancer
3.No prior chemotherapy except adjuvant therapy, with paclitaxel or nab-paclitaxel
4.No peripheral neuropathy (PNQ<=1)
5.Adequate organ function shown in physical examinations within 14 days prior to enrollment
Neutrophil count >=2000/mm3
Platelet count >=100,000/mm3
Hemoglobin >=9.0g/dL
AST and ALT <=2.5 x upper limit of normal (ULN)
Total serum bilirubin <=l.5 xULN
Serum creatinine <=1.5 xULN
6.Electrocardiographic abnormality
7.Age of 20-75 years
8.ECOG PS 0-2

Key exclusion criteria

1.HER2 IHC3+ or FISH positive
2.History of medication or cold allergies
3.Inflammatory breast cancer
4.Suspected brachial plexus neuropathy due to spread of breast cancer
5.Clinically significant edema of the arm on the affected side
6.History of other malignancy except carcinoma in situ within the last 5 years
7.Clinically significant central nervous system metastases
8.Clinically significant third space fluid accumulation (effusion, ascites, pericardial fluid )
9.Active infection
10.Interstitial pneumonia or fibrosis of the lung
11.HBs antigen positive
12.Other concurrent severe and/or uncontrolled diabetes mellitus
13.Pregnant or nursing females
14.Not suitable for participation with any other reasons

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Toshinari
Middle name
Last name Yamashita

Organization

Kanagawa Cancer Center

Division name

Department of Breast and Endocrine Surgery

Zip code

241-8515

Address

2-3-2 Nakao, Asahi-ku, Yokohama

TEL

045-520-2222

Email

tyamashita@kcch.jp


Public contact

Name of contact person

1st name MD
Middle name
Last name PhD

Organization

Kanagawa Cancer Center

Division name

Department of Breast and Endocrine Surgery

Zip code

241-0815

Address

2-3-2 Nakao, Asahi-ku, Yokohama

TEL

045-520-2222

Homepage URL


Email

tyamashita@kcch.jp


Sponsor or person

Institute

Tokai Breast Cancer Clinical Research Group (TBCRG)

Institute

Department

Personal name



Funding Source

Organization

Tokai Breast Cancer Clinical Research Group (TBCRG)

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

IRB in Tokyo Metropolitan Komagome Hospital

Address

3-18-22 Honkomagome, Bunkyo-ku, Toky

Tel

03-3823-2101

Email

goto-tky@cick.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

愛知医科大学病院(愛知県)、愛知県がんセンター愛知病院(愛知県)、愛知県がんセンター中央病院(愛知県)、一宮市立市民病院(愛知県)、大垣市民病院(岐阜県)、春日井市民病院(愛知県)、.がん・感染症センター都立駒込病院(東京都)、岐阜県総合医療センター(岐阜県)、岐阜市民病院(岐阜県)、
岐阜大学医学部附属病院(岐阜県)、江南厚生病院(愛知県)、小牧市民病院(愛知県)、聖隷浜松病院(静岡県)、
総合上飯田第一病院(愛知県)、豊川市民病院(愛知県)、 トヨタ記念病院(愛知県)、
豊橋市民病院(愛知県)、名古屋医療センター(愛知県)、 名古屋市立西部医療センター(愛知県)、名古屋市立大学病院(愛知県)、名古屋第二赤十字病院(愛知県)、浜松医科大学医学部附属病院(静岡県)、 藤田保健衛生大学病院(愛知県)、丸茂病院(愛知県)、三重大学医学部附属病院(三重県)


Other administrative information

Date of disclosure of the study information

2012 Year 05 Month 15 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

Main results already published

Date of protocol fixation

2012 Year 05 Month 01 Day

Date of IRB

2011 Year 12 Month 14 Day

Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date

2015 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 05 Month 08 Day

Last modified on

2019 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009259


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name