NCT02468141已完成不适用
Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients: A Randomized Double Blinded Placebo Controlled Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SJDBT group
Experimental
Herbal medicine
干预措施: SJDBT (Drug)
Placebo
Placebo Comparator
Placebo control
干预措施: Placebo (Drug)
结局指标
主要结局
The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale
时间窗: 4 weeks
Function scores as measured by the likert scale
次要结局
- FAACT scale(4 weeks)
研究者
Seong-Gyu Ko
Professor
Kyunghee University Medical Center
研究点 (1)
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