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/A
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    32
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.
Study Started
Jul 31
2015
Primary Completion
Jun 30
2016
Study Completion
Sep 30
2016
Last Update
Jul 21
2017

Drug SJDBT

Sipjeondaebo-tang

  • Other names: Sipjeondaebotang

Drug Placebo

Placebo

  • Other names: Placebo control

SJDBT group Experimental

Herbal medicine

Placebo Placebo Comparator

Placebo control

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
No Results Posted