Title
Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients
Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients: A Randomized Double Blinded Placebo Controlled Pilot Study
Phase
N/ALead Sponsor
Kyung Hee UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Cancer-related Problem/ConditionIntervention/Treatment
sipjeondaebo-tang ...Study Participants
32To determine efficacy and safety of Sipjeondaebo-tang for Cancer patients suffering from anorexia after chemotherapy. Sipjeondaebo-tang will be administered for 4 weeks, 3 times per day after a meal. Changes of FAACT scale, Anorexia VAS, Weight, BMI, Clinical laboratory test such as ACTH, Cortisol, Chrelin, IL-6, ESR, CRP will be measured and analyzed.
Sipjeondaebo-tang
Placebo
Inclusion Criteria: Men and women ages 20 to 80 years Individuals who are suffering from cancer-associated anorexia Patients within 1 month after completion of chemotherapy No plan for additional chemotherapy or radiotherapy Anorexia visual analogue scale (VAS) ≥ 40/100mm Qi deficiency scale ≥ 30 or Blood deficiency scale ≥ 30 Neutrophil ≥ 1,500/㎕, platelet ≥ 100,000/㎕ Total bilirubin lower than upper limit of normal (1.2 mg/㎗) ALT, AST lower than 2-fold the upper limit of normal Creatinine lower than 1.5 fold the upper limit of normal(1.09 mg/㎗) Written informed consent for participation in the trial Exclusion Criteria: Patient impossible to oral intake Patient 5 years after cancer diagnosis ECOG performance status score > 3 Patient with dementia, delirium, depression Patient who complain of more than 7 points when we use Numeric Rating Scale, which can affect appetite or calorie intake, within 2 weeks of screening Patient with diseases which can influence on appetite (such as hypoadrenalism, etc) Patient who are taking appetizers (such as megestrol acetate, corticosteroids, thalidomide) Women who has possibility of a pregnancy Others who are judged not to be appropriate to study