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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyunghee University Medical Center
• Treatments: Juzentaihoto

Criteria

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