Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients

Kyung Hee University

Status

Completed

Conditions

Cancer-related Problem/Condition

Treatments

Drug: SJDBT

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02468141

KCRD_SJDBT_2015

Details and patient eligibility

About

To 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.

Enrollment

32 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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