Electroacupuncture for Xerostomia in Head and Neck Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Subjective sensation of mouth dryness as measured by quality of life questionnaires at baseline, on days 5 and 10 of treatment, and at 1, 3, and 6 months after completion of treatment
研究概览
简要总结
RATIONALE: Electroacupuncture may help relieve chronic dry mouth caused by radiation therapy. It is not yet known whether electroacupuncture is more effective than a placebo in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.
PURPOSE: This randomized clinical trial is studying electroacupuncture to see how well it works compared with a placebo in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.
详细描述
OBJECTIVES:
- To determine if electrostimulation using the Liss stimulator can objectively improve salivary flow as measured by sialometry compared to a placebo device in patients with chronic radiation-induced xerostomia and head and neck cancer.
- To determine if electrostimulation using the Liss Stimulator can improve the subjective sensation of mouth dryness compared to a placebo device.
- To characterize the effect of electrostimulation using the Liss stimulator on quality of life compared to a placebo device.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo placement of electrodes to the following acupuncture points: stomach, liver, pericardium, small intestine, and large intestine. Patients then undergo electro-stimulation of the acupuncture points using the Liss Stimulator for 20 minutes once a day for 10 days and then 3 times a week for 2 weeks.
- Arm II (placebo): Patients undergo placement of electrodes to the following acupuncture points: stomach, liver, pericardium, small intestine, and large intestine. A device that does not produce an electric current is placed over the electrodes for 20 minutes once a day for 10 days and then 3 times a week for 2 weeks.
Patients complete questionnaires, including the Brief Pain Inventory, the Xerostomia Inventory, and a subscale of the University of Washington Head and Neck Symptom Scale, at baseline, on days 5 and 10 of treatment, and at 1, 3, and 6 months after completion of treatment. Sialometry (unstimulated and stimulated whole saliva measurement) is also performed at the same time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Single
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Subjective sensation of mouth dryness as measured by quality of life questionnaires at baseline, on days 5 and 10 of treatment, and at 1, 3, and 6 months after completion of treatment
Salivary flow as measured by sialometry at baseline, on days 5 and 10 of treatment, and at 1, 3, and 6 months after completion of treatment
Quality of life as measured by quality of life questionnaires at baseline, on days 5 and 10 of treatment, and at 1, 3, and 6 months after completion of treatment
次要结局
未报告次要终点