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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients: A Randomized Double Blinded Placebo Controlled Pilot Study

Conditions
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Cancer-related Problem/Condition

Intervention / Treatment
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* Drug: SJDBT
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SJDBT group<br>Herbal medicine | Drug: SJDBT<br>* Sipjeondaebo-tang<br>* Other names: Sipjeondaebotang;|
| Placebo Comparator: Placebo<br>Placebo control | Drug: Placebo<br>* Placebo<br>* Other names: Placebo control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale | Function scores as measured by the likert scale | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FAACT scale |  | 4 weeks |