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
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
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
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
