UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006306 |
|---|---|
| Receipt number | R000007468 |
| Scientific Title | Time to improvement in patient with paclitaxel -induced peripheral neurotoxicity in patients with breast cancer. |
| Date of disclosure of the study information | 2011/09/07 |
| Last modified on | 2011/09/07 20:28:54 |
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Basic information
Public title
Time to improvement in patient with paclitaxel -induced peripheral neurotoxicity in patients with breast cancer.
Acronym
Time to improvement in patient with paclitaxel -induced peripheral neurotoxicity in patients with breast cancer.
Scientific Title
Time to improvement in patient with paclitaxel -induced peripheral neurotoxicity in patients with breast cancer.
Scientific Title:Acronym
Time to improvement in patient with paclitaxel -induced peripheral neurotoxicity in patients with breast cancer.
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate time to improvement for nab-paclitaxel -induced peripheral neurotoxicity in comparison with paclitaxel.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to improvement chemotherapy -induced peripheral neurotoxicity is evaluated with CTCAE v4.0, PNQ
Key secondary outcomes
Freguency, severity of peripheral neurotoxicity
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Female
Key inclusion criteria
1)breast cancer patient scheduled for treatment with Paclitaxel or nab-Paclitaxel
2) age: >=20
3) ECOG performance status of 0 or 1 or 2
4)required baseline laboratory parameters
5)expected more than 6 months survival
6)written informed consent
Key exclusion criteria
1)with severe complications (such as liver failure, renal failure, heart failure)
2)with history of allergy
3)with peripheral neuropathy for other cause (such as severe edema, diabetes, vitamin B12 deficiency)
4)doctor's decision not to be registered to this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ishikawa |
Organization
Yokohama City University Medical Center
Division name
Breast and thyroid surgery
Zip code
Address
4-57, Urafuna-cho, Minami-ku, Yokohama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Ishikawa |
Organization
Yokohama City University Medical Center
Division name
Breast and thyroid surgery
Zip code
Address
4-57, Urafuna-cho, Minami-ku, Yokohama
TEL
045-261-5656
Homepage URL
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
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
| 2011 | Year | 09 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate time to improvement for nab-paclitaxel -induced peripheral neurotoxicity in comparison with paclitaxel.
Management information
Registered date
| 2011 | Year | 09 | Month | 07 | Day |
Last modified on
| 2011 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007468
