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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004416
Receipt No. 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

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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
Institute Cancer Institute Hospital Breast Center
Institute
Department

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
URL(English) https://upload.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


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