The Traditional Chinese Medicine Department of Xin Qiao Hospital
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Appetite Visual Analog Scale
研究概览
简要总结
This trail will be carried out to evaluated the effect and safety of acupuncture for the anorexia in patients with gastrointestinal tract and lung cancers.
详细描述
Acupuncture used for anorexia related to cancer, but there were lack of powerful evidence. The 160 eligibilities will be randomly divided into 3 groups(Acupuncture and Placebo group, Megestrol acetate and Sham Acupuncture group, Placebo and Sham Acupuncture group).The effect will be investigated baseline, the 2,5,8 and 15days. The safety issue will be recorded every section during the acupuncture.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed gastrointestinal tand lung cancers;
- •Age ≥18 years;
- •Appetite score≤ 6 (0= worst appetite), and the symptom lasted 2 weeks at lest at screening;
- •Had a history of weight loss ≥5% within 6 moths;
- •Maintained oral intake;
- •Signed the informed consent.
排除标准
- •Patients with dementia, delirium, intestinal obstruction, pregnancy or lactation;
- •Had uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression(The score of the symptoms≤ 3, 0= worst) ;
- •Patients with untreated vitamin B12 deficiency or endocrine abnormalities(thyroid dysfunction and hypoadrenalism);
- •Patients on melatonin supplements or medications with potential appetite-stimulating activity(Chinese herb,thalidomide)
- •Less than one week before the screening or there will be a surgery ,radiotherapy and chemotherapy the acupuncture;
- •Lifetime expected less than 3 months.
研究组 & 干预措施
Acupuncture+Placebo
Acupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days.
干预措施: Acupuncture (Other)
Acupuncture+Placebo
Acupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days.
干预措施: Placebo(Megestrol Acetate) (Drug)
Megestrol Acetate+Sham acupuncture
Megestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
干预措施: Sham Acupuncture (Other)
Megestrol Acetate+Sham acupuncture
Megestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
干预措施: Megestrol Acetate (Drug)
Placebo+Sham acupuncture
Placebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
干预措施: Sham Acupuncture (Other)
Placebo+Sham acupuncture
Placebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .
干预措施: Placebo(Megestrol Acetate) (Drug)
结局指标
主要结局
Appetite Visual Analog Scale
时间窗: Baseline, the days 8 and 15.
The assessment will be done thirty minutes before meals. The participators should record the score of their appetite (0 to 100 mm) the higher scores reflect better symptom control.
次要结局
- Council of Nutrition appetite questionnaire (CNAQ)(Baseline, the days 8 and 15.)
- Caloric intake(Baseline, the days 8 and 15.)
- Functional Assessment of Anorexia/Cachexia Therapy(Baseline, the days 8 and 15.)
- Nutritional status(Baseline, the days 8 and 15.)
研究者
Chaoting Zhao
Vice Director, Clinical Reseach
Xinqiao Hospital of Chongqing