UMIN-CTR Clinical Trial

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
Institute	Tokai Breast Cancer Clinical Research Group (TBCRG)
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009259