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

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 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

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

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