Research Article

Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial

Box 1

Participants eligibility criteria.
Inclusion criteria
(1) men and women aged 20 to 80 years
(2) patients who have histologically or cytologically confirmed solid tumor
(3) patients who are suffering from anorexia
(4) patients within 1 month after completion of chemotherapy
(5) no plan for additional chemotherapy or radiotherapy
(6) anorexia VAS ≥ 40/100 mm
(7) Qi deficiency scale ≥ 30 or Blood deficiency scale ≥ 30
(8) neutrophil ≥ 1,500/μl, platelet ≥ 100,000/μl
(9) total bilirubin of the maximum normal level or less (1.2 mg/dl)
(10) alanine aminotransferase (ALT), aspartate aminotransferase (AST) lower than 2-fold the upper limit of
   normal
(11) creatinine lower than 1.5 fold the upper limit of normal (1.09 mg/dl)
(12) written informed consent for participation in the trial
Exclusion criteria
(1) impossible to intake orally
(2) survived at least 5 years after cancer diagnosis
(3) Eastern Cooperative Oncology Group (ECOG) performance status score > 3
(4) Patients who have dementia, delirium or depression
(5) reports more than 7 points of Numeric Pain Rating Scale
(6) Patients who have diseases like hypoadrenalism which can influence on appetite
(7) taking palliative medicines such as megestrol acetate, corticosteroids, and thalidomide
(8) women of childbearing potential
(9) others who are judged not to be appropriate to study