UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027481 |
|---|---|
| Receipt number | R000031481 |
| Scientific Title | Randomized study of Sokei-Kakketsu-To for the Reduction of Aromatase Inhibitor - Associated Joint Symptoms in Women with Breast Cancer |
| Date of disclosure of the study information | 2017/05/25 |
| Last modified on | 2019/01/07 08:05:54 |
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Basic information
Public title
Randomized study of Sokei-Kakketsu-To for the Reduction of Aromatase Inhibitor - Associated Joint Symptoms in Women with Breast Cancer
Acronym
Randomized study of Sokei-Kakketsu-To for the Reduction of Aromatase Inhibitor - Associated Joint Symptoms
Scientific Title
Randomized study of Sokei-Kakketsu-To for the Reduction of Aromatase Inhibitor - Associated Joint Symptoms in Women with Breast Cancer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shinji Ozaki |
Organization
National Hospital Organization Kure Medical Center/Chugoku Cancer Center
Division name
Department of Breast Surgery
Zip code
Address
3-1 Aoyama-cho, Kure-shi, Hiroshima, JAPAN, 737-0023
TEL
0823-22-3111
ozakis@kure-nh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Ozaki |
Organization
National Hospital Organization Kure Medical Center/Chugoku Cancer Center
Division name
Department of Breast Surgery
Zip code
Address
3-1 Aoyama-cho, Kure-shi, Hiroshima, JAPAN, 737-0023
TEL
0823-22-3111
Homepage URL
ozakis@kure-nh.go.jp
Sponsor or person
Institute
National Hospital Organization Kure Medical Center/Chugoku Cancer Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 05 | Month | 09 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031481
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
