Clinical Trial of Sipjeondaebo-tang on Fatigue of Breast Cancer Patients
Not Applicable
- Conditions
- Breast Carcinoma
- Interventions
- Drug: Sipjeondaebo-tang
- Registration Number
- NCT02858856
- Lead Sponsor
- Kyunghee University Medical Center
- Brief Summary
This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A group Sipjeondaebo-tang Take Sipjeondaebo-tang on 0\~2 week, 3\~5 week of clinical trial period, total of 4 weeks B group Sipjeondaebo-tang Take Sipjeondaebo-tang on 6\~8 week, 9\~11 week of clinical trial period, total of 4 weeks
- Primary Outcome Measures
Name Time Method Brief Fatigue Inventory change 6-11 week
- Secondary Outcome Measures
Name Time Method EORTC-QLQ-C30 change 0-5 week, 6-11 week EORTC-QLQ-BR23 change 0-5 week, 6-11 week
Trial Locations
- Locations (1)
International St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of