Breast Carcinoma
Conditions
Brief summary
This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.
Interventions
DRUGSipjeondaebo-tang
Herbal medicine which is a compound of 10 herbs.
Sponsors
Catholic Kwandong University
Kyunghee University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brief Fatigue Inventory change | 0-5 week |
Secondary
| Measure | Time frame |
|---|---|
| EORTC-QLQ-C30 change | 0-5 week, 6-11 week |
| EORTC-QLQ-BR23 change | 0-5 week, 6-11 week |
Countries
South Korea
Contacts
Primary ContactChunhoo Cheon
Outcome results
None listed