Title
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
Phase
N/ALead Sponsor
Kyung Hee UniversityStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Breast CarcinomaIntervention/Treatment
deciten ...Study Participants
48This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.
Herbal medicine which is a compound of 10 herbs.
Take Sipjeondaebo-tang on 0~2 week, 3~5 week of clinical trial period, total of 4 weeks
Take Sipjeondaebo-tang on 6~8 week, 9~11 week of clinical trial period, total of 4 weeks
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