UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized study of Sokei-Kakketsu-To for the Reduction of Aromatase Inhibitor - Associated Joint Symptoms in Women with Breast Cancer
Title of the study (Brief title)	Randomized study of Sokei-Kakketsu-To for the Reduction of Aromatase Inhibitor - Associated Joint Symptoms
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Hematology and clinical oncology Breast surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Validation of Sokei-Kakketsu-To (TJ-53) for the reduction of aromatase inhibitor associated joint symptoms in women with breast cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Effectiveness in the treatment of TJ-53 to the aromatase inhibitor associated joint symptoms at 3 months. HAQ-DI (Health Assessment Questionnaire-Disability Index) will be used for the assessment of the effectiveness.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Behavior,custom
Interventions/Control_1	Oral treatment of Sokei-Kakketsu-To(TJ-53) for 3 months
Interventions/Control_2	Joint exercises
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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Female
Key inclusion criteria	Breast cancer patients treated with Aromatase inhibitor(any of Aromatase Inhibitors: Letrozole, Anastrozole and Exemestane) who developed joint symptoms or worsend the symptoms
Key exclusion criteria	1. Patients having neurological disorder, collagen disease and orthopedic disease who show the similar joint symptoms. 2. Patients treated with medicine that may affect the joint symptoms (NSAIDs, Acetaminophen or Opioids etc.)
Target sample size	68

Research contact person
Name of lead principal investigator	Shinji Ozaki
Organization	National Hospital Organization Kure Medical Center/Chugoku Cancer Center
Division name	Department of Breast Surgery
Address	3-1 Aoyama-cho, Kure-shi, Hiroshima, JAPAN, 737-0023
TEL	0823-22-3111
Email	ozakis@kure-nh.go.jp

Public contact
Name of contact person	Shinji Ozaki
Organization	National Hospital Organization Kure Medical Center/Chugoku Cancer Center
Division name	Department of Breast Surgery
Address	3-1 Aoyama-cho, Kure-shi, Hiroshima, JAPAN, 737-0023
TEL	0823-22-3111
Homepage URL
Email	ozakis@kure-nh.go.jp

Sponsor
Institute	National Hospital Organization Kure Medical Center/Chugoku Cancer Center
Institute
Department

Funding Source
Organization	National Hospital Organization Kure Medical Center/Chugoku Cancer Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 05 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 05 Month 09 Day
Anticipated trial start date	2017 Year 05 Month 19 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry	2024 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 24 Day
Last modified on	2019 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031481