Cancer-related Problem/Condition
Conditions
Brief 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.
Interventions
DRUGSJDBT
Sipjeondaebo-tang
DRUGPlacebo
Placebo
Sponsors
Kyunghee University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale | 4 weeks | Function scores as measured by the likert scale |
Secondary
| Measure | Time frame |
|---|---|
| FAACT scale | 4 weeks |
Countries
South Korea
Outcome results
None listed