UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054353 |
|---|---|
| Receipt number | R000061684 |
| Scientific Title | Prospective observational study on the search for factors, including Kampo medicine treatment, that affect adverse symptoms associated with endocrine therapy and work activity in breast cancer patients. |
| Date of disclosure of the study information | 2024/05/09 |
| Last modified on | 2024/08/18 13:20:08 |
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Basic information
Public title
Study on the search for factors, including Kampo medicine treatment, that affect adverse symptoms associated with endocrine therapy and work activity in breast cancer patients.
Acronym
Treatment-Related Factors Affecting Adverse Symptoms and Work Activity Associated with Endocrine Therapy in Breast Cancer Patients
Scientific Title
Prospective observational study on the search for factors, including Kampo medicine treatment, that affect adverse symptoms associated with endocrine therapy and work activity in breast cancer patients.
Scientific Title:Acronym
Prospective observational study on the search for factors, including Kampo medicine treatment, that affect adverse symptoms associated with endocrine therapy and work activity in breast cancer patients.
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Regularly treat breast cancer patients on endocrine therapy, including the use of Kampo medicines, to explore the course of symptoms, impact on quality of life (QOL), and impact on employment.
Basic objectives2
Others
Basic objectives -Others
Course of symptoms, impact on quality of life (QOL), impact on employment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
subjective symptoms
Key secondary outcomes
EQ-5D-5L
WPAI-GH
FACT-B
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Disease: First-episode breast cancer
(2) Clinical stage: Stage 0 to Stage III (according to the following classification)
(3) Age: 20 years of age or older at the time of consent
(4) Gender: Female
(5) The patient is undergoing endocrine therapy for breast cancer (more than 28 days after the start of endocrine therapy) and has not been prescribed any Chinese herbal medicine for side effects of endocrine therapy for breast cancer
(6) Having adverse symptoms (vasomotor ataxia, physical symptoms, psychiatric symptoms) after endocrine therapy for breast cancer (over 4 for at least one symptom on NRS 0-10)
(7) Performance status (ECOG scale) of 0 or 1
(8) Have obtained written consent to participate in the study
(9) Able to input data via the Internet from a device such as a PC, tablet, or smartphone.
Key exclusion criteria
(1) Have a serious concomitant disease (liver disease: cirrhosis, renal disease: on dialysis, cardiac disease: chronic heart failure, hematological disease: leukemia, or metabolic disease: poorly controlled diabetes, etc.)
(2) Women who are pregnant, may become pregnant (only if they wish to become pregnant during the study period), or are breastfeeding
(3) Have concurrent overlapping cancers
(4) Any other cases in which the principal investigator or subinvestigator determines that the subject is inappropriate as a research subject.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Takayama |
Organization
Tohoku University Hospital
Division name
Department of Education and Support for Regional Medicine
Zip code
9808574
Address
1-1, Seiryo-machi, Aoba ward, Sendai, Japan
TEL
0227177507
takayama@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Takayama |
Organization
Tohoku University Hospital
Division name
Department of Education and Support for Regional Medicine
Zip code
9808574
Address
1-1, Seiryo-machi, Aoba ward, Sendai, Japan
TEL
0227177507
Homepage URL
takayama@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba ward, Sendai, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 05 | Month | 09 | Day |
Last modified on
| 2024 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061684
