Clinical Trial of Sipjeondaebo-tang on Fatigue of Breast Cancer Patients
Sipjeondaebo-tang for Alleviating Fatigue Measured by Brief Fatigue Inventory and EORTC-QLQ-C30, BR23 Score Change Among Patients With Breast Carcinoma Receiving Chemotherapy
1 other identifier
interventional
48
1 country
1
Brief Summary
This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2016
CompletedFirst Posted
Study publicly available on registry
August 8, 2016
CompletedStudy Start
First participant enrolled
March 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedSeptember 15, 2017
September 1, 2017
12 months
July 30, 2016
September 14, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Brief Fatigue Inventory change
0-5 week
Brief Fatigue Inventory change
6-11 week
Secondary Outcomes (2)
EORTC-QLQ-C30 change
0-5 week, 6-11 week
EORTC-QLQ-BR23 change
0-5 week, 6-11 week
Study Arms (2)
A group
EXPERIMENTALTake Sipjeondaebo-tang on 0\~2 week, 3\~5 week of clinical trial period, total of 4 weeks
B group
EXPERIMENTALTake Sipjeondaebo-tang on 6\~8 week, 9\~11 week of clinical trial period, total of 4 weeks
Interventions
Herbal medicine which is a compound of 10 herbs.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyunghee University Medical Centerlead
- Catholic Kwandong Universitycollaborator
Study Sites (1)
International St. Mary's Hospital
Incheon, 22711, South Korea
Related Publications (1)
Cheon C, Kang S, Ko Y, Kim M, Jang BH, Shin YC, Ko SG. Sipjeondaebo-tang in patients with breast cancer with fatigue: a protocol for a pilot, randomised, double-blind, placebo-controlled, cross-over trial. BMJ Open. 2018 Jul 6;8(7):e021242. doi: 10.1136/bmjopen-2017-021242.
PMID: 29982213DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
July 30, 2016
First Posted
August 8, 2016
Study Start
March 20, 2017
Primary Completion
March 1, 2018
Study Completion
June 1, 2018
Last Updated
September 15, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share