Prospective Study of Non-invasive Acupuncture-like Transcutaneous Electrical Nerve Stimulation (Altens) to Help Alleviate Xerostomia After Radiation Therapy for Cancers of the Head and Neck
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Number of patients with a mean parotid dose > 25 Gy have an improvement on the XeQoL questionnaire that is significantly different than those with a mean dose < 25 Gy
研究概览
简要总结
The purpose of this study would like to learn if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth.
详细描述
In this study the investigator would like to better understand if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth. Acupuncture has been shown to help some people with symptoms of dry mouth, and low-level electrical stimulation of acupuncture points has been shown to have similar results as acupuncture treatment with needles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age > 18 years
- •No restrictions on gender or ethnicity
- •Ability and willingness to present for ALTENS therapy over 12 weeks
- •Previous radiation to the head and neck with a dose > 50 Gy
- •Subjective complaint of dry mouth
- •No evidence of active malignancy in the head and neck region
- •Minimum of 3 months post initial curative therapy with no evidence of active disease by standard of care surveillance scans for said disease site
排除标准
- •Age under 18 years of age
- •Inability to present for ALTENS therapy
- •Inability to fill out quality of life questionnaires
- •Ability and desire to receive concurrent chemoradiation therapy
- •Because ALTENs may stimulate nerves similar to those of pilocarpine, the following exclusions are noted as theoretically ALTENS could produce worse symptoms
- •Unstable Angina
- •Unstable cardiac disease with hospitalization in the last 6 months
- •Presence of a pacemaker, ICD, or other electronic implanted device that could be affected
- •Myocardial infarction in the last 6 months
- •Symptomatic arrhythmia in the last 6 months
- •Severe COPD with exacerbation causing hospitalization within the last 6 months
- •Pregnancy or the possibility of pregnancy
结局指标
主要结局
Number of patients with a mean parotid dose > 25 Gy have an improvement on the XeQoL questionnaire that is significantly different than those with a mean dose < 25 Gy
时间窗: 6 Months
Measure by responses to XeQoL questionnaire
次要结局
- Incidence of Treatment-Related Adverse Events [Safety and Tolerability](6 Months)
研究者
Michael Cummings
Assistant Professor - Department of Radiation Oncology (SMD)
University of Rochester