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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name