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
- 1
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of primary head and neck cancer
- •Has undergone radiotherapy either as primary or adjuvant therapy ≥ 6 months ago
- •One or more parotid glands must have been in the prior radiotherapy field
- •Residual xerostomia after radiotherapy deemed to be significant by patient
- •Failed to respond to a trial of pilocarpine for relief of xerostomia
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-3
- •Life expectancy ≥ 1 year (based on physician's judgment)
- •Able to attend the scheduled study treatments
- •Alert and mentally competent
- •Not pregnant
- •Willing to use contraception during study treatment, if of childbearing age
- •No history of Sjögren's disease
- •No cardiac pacemaker or any other electrical devices permanently implanted within the body (e.g., dorsal column stimulator)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 2 weeks since prior medication that may cause mouth dryness (e.g., antihistamines, narcotics, tricyclic antidepressants)
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