UMIN-CTR Clinical Trial

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

Contact us.