UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of hydroxocobalamin acetate in patients with taxane-induced sensory peripheral neuropathy A multi-center, observational study(HAPPY study)
Title of the study (Brief title)	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	Aya Watanabe
Organization	Research hospital, the Institute of Medical Science,the University of Tokyo
Division name	Department of Palliative Oncology/Department of Pharmacy
Address	4-6-1, Shirokanedai, Minato-ku, Tokyo. 108-8639 Japan
TEL	03-5449-5565
Email	aya1219-tky@umin.ac.jp

Public contact
Name of contact person	Hiroto Ishiki
Organization	Research hospital, the Institute of Medical Science,the University of Tokyo
Division name	Department of Palliative Oncology
Address	4-6-1, Shirokanedai, Minato-ku, Tokyo. 108-8639 Japan
TEL	03-3443-8111
Homepage URL
Email	ishiki-tky@umin.ac.jp

Sponsor
Institute	Research hospital, the Institute of Medical Science,the University of Tokyo
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025685