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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002455
Receipt No. R000002659
Scientific Title Study of Arthralgia and Vasomotor Symptoms in Japanese Postmenopausal Women Treated with Anastrozole
Date of disclosure of the study information 2009/09/06
Last modified on 2020/03/15

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Basic information
Public title Study of Arthralgia and Vasomotor Symptoms in Japanese Postmenopausal Women Treated with Anastrozole
Acronym SAVS-JP
Scientific Title Study of Arthralgia and Vasomotor Symptoms in Japanese Postmenopausal Women Treated with Anastrozole
Scientific Title:Acronym SAVS-JP
Region
Japan

Condition
Condition Postmenopausal breast cancers
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Evalation of arthralgia symptoms among postmenopasual Japanese breast cancer patients treated with anastrozole.
Basic objectives2 Others
Basic objectives -Others Analysis of symptoms accompanied with the drug.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of arthralgian and vasomotor symptoms.
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Postmenopausal breast cancer patients.
Key exclusion criteria Bilateral breast cancer
Double cancer within 5 years after treatment
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Yasuo
Middle name
Last name Miyoshi
Organization Hyogo College of Medicine
Division name Department of Surgery, Division of Breast and Endocrine Surgery
Zip code 663-8501
Address 1-1 Mukogawacho, Nishinomiya city, Hyogo
TEL 0798456374
Email ymiyoshi@hyo-med.ac.jp

Public contact
Name of contact person
1st name Yasuo
Middle name
Last name Miyoshi
Organization Hyogo College of Medicine
Division name Department of Surgery, Division of Breast and Endocrine Surgery
Zip code 663-8501
Address 1-1 Mukogawa Nishinomiya
TEL 0798456374
Homepage URL
Email ymiyoshi@hyo-med.ac.jp

Sponsor
Institute Department of Surgery, Hyogo College of Medicine
Institute
Department

Funding Source
Organization Funding of Hyogo College of Medicine
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 Institutional Review Board of Hyogo College of Medicine
Address Mukogawa 1-1, Nishinomiya City
Tel 0798456374
Email rinri@hyo-med.ac.jp

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 兵庫医科大学、兵庫県立がんセンター、関西ろうさい病院、さきたクリニック、神鋼病院、甲南病院、兵庫県立西宮病院、茶屋町ブレストクリニック
、西神戸医療センター、明和病院、尼崎厚生会立花病院、神戸百年記念病院、川西市立川西病院、岡本クリニック、伊丹市立伊丹病院、兵庫県立加古川病院、隈病院、六甲アイランド病院、近畿中央病院、県立塚口病院、大山病院、橋本クリニック、みやうちクリニック、にしかわクリニック、新日鐡広畑病院、神戸市立医療センター中央市民病院、協同病院、宝塚市立病院、神戸大学 乳腺・内分泌外科、こくふブレストクリニック、西田クリニック

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 06 Day

Related information
URL releasing protocol Unpublished
Publication of results Partially published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/26411314
Number of participants that the trial has enrolled 391
Results
PROs from 362 patients (92.6 %) were obtained. New or worsening from baseline of joint symptoms were reported by 260 patients (71.8 %). More than 90 % of the symptoms were mild or moderate. Multivariate analysis showed that a short time span after menopause [odds ratio (OR) 0.95, 95 % confidence interval (CI) 0.90-0.99; P = 0.02] and adjuvant chemotherapy (OR 2.29, 95 % CI 1.06-4.95; P = 0.03) were significant independent risk factors for joint symptoms.
Results date posted
2020 Year 03 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2016 Year 04 Month 21 Day
Baseline Characteristics
Patients treated with anastorozole
Participant flow
Recruited after obtained informed consent
Adverse events
Arthralgia  166 (54.4 %)
Decrease of joint motion  104 (34.1 %)
Joint stiffness  182 (59.7 %)
Outcome measures
Frequency of new or worsening from baseline of joint symptoms
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 07 Month 07 Day
Date of IRB
2009 Year 07 Month 12 Day
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The frequency of side effects will be evaluated by questionaries.

Management information
Registered date
2009 Year 09 Month 06 Day
Last modified on
2020 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002659

Research Plan
Registered date File name
2020/03/15 SAVS-JP申請(修正)09.8.8.doc

Research case data specifications
Registered date File name
2020/03/15 130405 ホルモン療法に伴う症状に関する問診票.xls

Research case data
Registered date File name
2020/03/15 130405 ホルモン療法に伴う症状に関する問診票.xls


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