UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002455 |
|---|---|
| Receipt number | 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 12:42:20 |
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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
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
ymiyoshi@hyo-med.ac.jp
Sponsor or person
Institute
Department of Surgery, Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/2659
