UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004416
Receipt number R000005255
Scientific Title Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms
Date of disclosure of the study information 2010/11/01
Last modified on 2016/01/24 19:22:04

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Basic information

Public title

Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms

Acronym

Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms (Juvera trial)

Scientific Title

Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms

Scientific Title:Acronym

Japanese study for usefulness of vitamin E in reducing aromatase inhibitor-associated joint symptoms (Juvera trial)

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate safety and efficacy of vitamin E in alleviating aromatase inhibitor-associated joint symptom

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Serum concentration of estrogen

Key secondary outcomes

Efficacy for joint symptom, adverse event, serum concentration of vitamin E and IL-6


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Medication of vitamin E

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

50 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Postmenopausal breast cancer patients who are aged 50 and over, received surgery and/or adjuvant chemotherapy and/or postsurgical radiotherapy, and currently taking a aromatase inhibitor as adjuvant hormone therapy
Patients who report CTC Grade 2 or 3 arthralgia after initiation of aromatase inhibitor therapy
Patients whose written informed consent are available

Key exclusion criteria

Patients who are suffering bone or joint disease, such as rheumatoid arthritis, osteoarthritis deformans, frozen shoulder syndrome, severe osteoporosis etc.
Previous history of neurological disorder
Recurrent breast cancer cases
Vitamin E users as supplement
Patients who are taking a anticoagulant or are expected surgery

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masujiro Makita

Organization

Cancer Institute Hospital Breast Cente

Division name

Breast Oncology

Zip code


Address

3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan

TEL

03-3520-0111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masujiro Makita

Organization

Cancer Institute Hospital Breast Center

Division name

Breast Oncology

Zip code


Address


TEL


Homepage URL


Email

mmakita@jfcr.or.jp


Sponsor or person

Institute

Cancer Institute Hospital Breast Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tokyo University of Pharmacy and Life Sciences, Department of Clinical Pharmacology

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

2010 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

The osteoarthropathy scores significantly decreased after vitamin E administration (p=0.0243), while serum-estradiol concentrations did not change. The serum-estradiol concentrations before vitamin E administration in the group sensitive to the vitamin E efficacy were significantly lower, as compared with those in the insensitive group (p=0.0005).

J Cancer 6(4): 367-376. 2015

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

2010 Year 10 Month 06 Day

Date of IRB


Anticipated trial start date

2010 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 10 Month 19 Day

Last modified on

2016 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005255


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name