- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02858856
Clinical Trial of Sipjeondaebo-tang on Fatigue of Breast Cancer Patients
September 14, 2017 updated by: Seong-Gyu Ko, Kyunghee University Medical Center
Sipjeondaebo-tang for Alleviating Fatigue Measured by Brief Fatigue Inventory and EORTC-QLQ-C30, BR23 Score Change Among Patients With Breast Carcinoma Receiving Chemotherapy
This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chunhoo Cheon
- Phone Number: 8229619278
- Email: khuksg@gmail.com
Study Locations
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-
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Incheon, Korea, Republic of, 22711
- Recruiting
- International St. Mary's hospital
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Contact:
- CHUNHOO CHEON, M.D.(DKM)
- Phone Number: 82-2-961-9278
- Email: hreedom35@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- men and women aged over 18 years
- patients who have histologically or cytologically confirmed breast tumor
- patients who applicable AC(doxorubicin + cyclophosphamide)
- ECOG score 0 to 2
Exclusion Criteria:
- patient impossible to orally intake
- patient with dementia, delirium and depression
- patient suffering from diseases like chronic hepatitis B, C or hepatocirrhosis
- severe liver disability (3-fold the normal high range value for ALT, AST)
- patient who has diabetes not controlled by diet, hypertension, hyperthyroidism,
- severe systemic disease
- use of other investigational products within the past 30 days
- hypersensitivity to investigational product
- others who are judged not to be appropriate to study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A group
Take Sipjeondaebo-tang on 0~2 week, 3~5 week of clinical trial period, total of 4 weeks
|
Herbal medicine which is a compound of 10 herbs.
Other Names:
|
Experimental: B group
Take Sipjeondaebo-tang on 6~8 week, 9~11 week of clinical trial period, total of 4 weeks
|
Herbal medicine which is a compound of 10 herbs.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Brief Fatigue Inventory change
Time Frame: 0-5 week
|
0-5 week
|
Brief Fatigue Inventory change
Time Frame: 6-11 week
|
6-11 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
EORTC-QLQ-C30 change
Time Frame: 0-5 week, 6-11 week
|
0-5 week, 6-11 week
|
EORTC-QLQ-BR23 change
Time Frame: 0-5 week, 6-11 week
|
0-5 week, 6-11 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2017
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
July 30, 2016
First Submitted That Met QC Criteria
August 3, 2016
First Posted (Estimate)
August 8, 2016
Study Record Updates
Last Update Posted (Actual)
September 15, 2017
Last Update Submitted That Met QC Criteria
September 14, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISEE_2016_SJDBT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedInvasive Breast Carcinoma | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Estrogen Receptor Negative | Estrogen Receptor Positive | Lobular Breast Carcinoma | Postmenopausal | Ductal Breast Carcinoma | Ductal Breast Carcinoma In SituUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); Cianna Medical, Inc.TerminatedStage I Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIC Breast Cancer | Lobular Breast Carcinoma In Situ | Estrogen Receptor Negative | Estrogen Receptor Positive | HER2/Neu Negative | Progesterone Receptor Positive | Ductal Breast Carcinoma In Situ | Mucinous Breast Carcinoma | Tubular Breast Carcinoma and other conditionsUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage IA Breast Cancer | Stage IB Breast Cancer | Recurrent Breast Cancer | Ductal Breast Carcinoma in Situ | Invasive Lobular Breast Carcinoma | Lobular Breast Carcinoma in Situ | Invasive Ductal Breast CarcinomaUnited States
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Case Comprehensive Cancer CenterWithdrawnStage I Breast Cancer | HER2-positive Breast Cancer | Male Breast Cancer | Stage II Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast Cancer | HER2-negative Breast... and other conditionsUnited States
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI); Canadian Cancer Trials GroupActive, not recruitingStage II Breast Cancer | Stage IIIA Breast Cancer | Invasive Breast Carcinoma | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Lobular Breast Carcinoma | Ductal Breast Carcinoma | Tubular Breast Carcinoma | Medullary Breast CarcinomaUnited States, Canada
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Ohio State University Comprehensive Cancer CenterWithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer | Ductal Breast Carcinoma in Situ | Lobular Breast Carcinoma in Situ
Clinical Trials on Sipjeondaebo-tang
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Gachon University Gil Oriental Medical HospitalKyung Hee University Hospital at Gangdong; Kyunghee University Medical Center; Sangji University Oriental Medical Hospital and other collaboratorsCompletedCold HypersensitivityKorea, Republic of
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Shanghai University of Traditional Chinese MedicineUnknownHeart Failure With Preserved Ejection FractionChina
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Guang'anmen Hospital of China Academy of Chinese...Tasly Pharmaceuticals, Inc.Completed
-
Gachon University Gil Oriental Medical HospitalDongGuk University; Sangji University Oriental Medical Hospital, KoreaCompleted
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China Medical University HospitalRecruiting
-
Gachon University Gil Oriental Medical HospitalDaejeon University; Semyung University Korean Medicine Hospital in Chungju; Woosuk...RecruitingChronic Low Back PainKorea, Republic of
-
Kyunghee University Medical CenterKorea Health Industry Development Institute; Gachon University Gil Medical...Completed
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Gachon University Gil Oriental Medical HospitalDongGuk University; Kyunghee University Medical Center; Wonkwang University Guangju... and other collaboratorsCompleted
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China Medical University HospitalUnknownGastroesophageal Reflux Disorder | Wu-Chu-Yu Tang | 24 Hours Esophageal PH and Multichannel Intraluminal Impedance TestingTaiwan
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Chinese University of Hong KongCompleted