UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022292 |
|---|---|
| Receipt number | R000025685 |
| Scientific Title | Efficacy and safety of hydroxocobalamin acetate in patients with taxane-induced sensory peripheral neuropathy A multi-center, observational study(HAPPY study) |
| Date of disclosure of the study information | 2016/05/13 |
| Last modified on | 2019/02/21 15:16:13 |
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Basic information
Public title
Efficacy and safety of hydroxocobalamin acetate in patients with taxane-induced sensory peripheral neuropathy A multi-center, observational study(HAPPY study)
Acronym
HAPPY study
Scientific Title
Efficacy and safety of hydroxocobalamin acetate in patients with taxane-induced sensory peripheral neuropathy A multi-center, observational study(HAPPY study)
Scientific Title:Acronym
HAPPY study
Region
| Japan |
Condition
Condition
sensory peripheral neuropathy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
I observe the patient receiving the hydroxocobalamin note for a breast cancer patient having sensory peripheral neuropathy with the taxane system anticancer medicine and examine the effectiveness and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRS
Key secondary outcomes
NRS, FACT/GOG-NTX-12, Adverse event
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Breast cancer is diagnosed histologically
2) A cancer is announced
3) An operation, the treatment by radiation are not planned during a study period
4) I have peripheral neuropathy (more than CTCAE Grade1) by the chemotherapy including of the past or taxane drugs taking effect now
5) The dosage of the hydroxocobalamin note is planned
6) Survival more than one month is expected
7) An answer is allowed by a question paper
8) The medical attendant judges that study entry is possible
Key exclusion criteria
1) There is the history of treatment by other peripheral neuropathy-related anticancer agents
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Aya Watanabe |
Organization
Research hospital, the Institute of Medical Science,the University of Tokyo
Division name
Department of Palliative Oncology/Department of Pharmacy
Zip code
Address
4-6-1, Shirokanedai, Minato-ku, Tokyo. 108-8639 Japan
TEL
03-5449-5565
aya1219-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroto Ishiki |
Organization
Research hospital, the Institute of Medical Science,the University of Tokyo
Division name
Department of Palliative Oncology
Zip code
Address
4-6-1, Shirokanedai, Minato-ku, Tokyo. 108-8639 Japan
TEL
03-3443-8111
Homepage URL
ishiki-tky@umin.ac.jp
Sponsor or person
Institute
Research hospital, the Institute of Medical Science,the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Research hospital, the Institute of Medical Science,the University of Tokyo
Department of Palliative Oncology
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 05 | Month | 13 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A study design: Observational study
A recruitment of target people method: The patient who it was approved participation facilities IRB in April, 2017 from May, 2016, and was equal to criteria for selection
An item to measure: Item (including NRS, FACT/GOG-NTX12) which I listed in end-point
Management information
Registered date
| 2016 | Year | 05 | Month | 12 | Day |
Last modified on
| 2019 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025685
