The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Simple Appetite Questionnaire
研究概览
简要总结
Controlling of cancer induced anorexia is highly demanded by advanced cancer patients. It plays an important role in improving the quality of life among advanced cancer patients. Through a randomized controlled single blinded clinical research, we will observe the differences of appetite, food intake amount, weight and KPS between the auricular needling treating group and control group before and after the treatment. Based on the results of the research, we can prove the clinical effectiveness of auricular needling in treating cancer induced anorexia and possible mechanism of the method.
详细描述
Patients will be recruited from Xiyuan Hospital. In this study, eligible participants will be randomly assigned to two groups. In the auricular needling treating group, patients will receive needling treating for 4 weeks(auricular needles are given to one ear every time for 2-3days,then switch to the other). Conventional nutrition support and symptomatic treatment are given at the same time. In the control group, patient just receive conventional nutrition support and symptomatic treatment.
The simple appetite questionnaire, a symptom based Anorexia assessment questionnaire and fatigue symptom inventory questionnaire are used to assess the condition of patients. Other observation index include weight, KPS, appetite and the expectation of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of malignant cancer of stage III or IV
- •Meet the diagnosis criteria of cancer induced anorexia
- •Karnofsky performance status(KPS) score≥ 60
- •Expected survival time≥3 months
- •Willing to give informed consent
- •Able to comply with trial protocol
排除标准
- •have blood routine, hepatic and renal disfunction,which is over 2 times of the normal value
- •obvious eating disorder, intestinal obstruction, poor controlled heart disease and diabetes
- •who are receiving progesterone, glucocorticoid or other hormone Therapy
- •those who are participating in other trials.
- •pregnant women, nursing mother or psychotic patients
结局指标
主要结局
Simple Appetite Questionnaire
时间窗: 10 weeks
The Simplified Nutritional Appetite Questionnaire (SNAQ) is used to assess the patient's appetite.Possible scores range from 4（poor appetite) to20（good appetite）.The score lower than 14 predicts a risk of 5% weight loss.
Symptom Based Anorexia Assessment
时间窗: 10 weeks
Symptom based anorexia assessment is used to evaluate whether and to what extent anorexia occurs in cancer patients.Possible scores range from 0(normal appetite) to 48(severe anorexia).After the patient answers all the questions in the table, the score is scored, and the final score is less than or equal to 24 points, which can be determined as anorexia.
次要结局
- Appetite Improvement(10 weeks)
- Weight(10 weeks)
- Acupuncture Treating Expectation Questionnaire(10 weeks)