Effectiveness of Acupuncture-like Transcutaneous Nerve Stimulation (ALTENS) in Improving Dysphagia and Associated Symptoms of Chemotherapy and/or Intensity Modulated Radiation Therapy (IMRT) for Head and Neck Cancers: A Pilot Study
试验速览
- 阶段
- 1 期
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in Subjective Dysphagia Assessment Score: EAT-10 from baseline
研究概览
简要总结
Study hypothesis: ALTENS techniques, administered within the first 3 months after radiation completion, can improve radiation-induced dysphagia and associated symptoms in head and neck cancer patients. This beneficial effect is mediated by the reduction of chronic inflammatory response of swallowing musculature to radiation, consequently a reduction in muscle fibrosis.
Primary study objective: To evaluate the effectiveness of ALTENS in relieving radiation-induced dysphagia. Eating Assessment Tool (EAT-10) scores will be used for this primary study endpoint.
详细描述
Difficulty in swallowing is a concerning symptom after radiation treatment for some types of head and neck cancers. Swallowing becomes difficult when radiation damage induces inflammation (with swelling and pain) in the inner covering tissues of the throat and muscles that involve in the swallowing process. Currently, supportive measures are used to manage this symptom while waiting for the tissue damages to heal. In some patients, the inflamed muscles develop scar tissues causing long-term swallowing difficulty and narrowing of the swallowing passage. Needle acupuncture may help to reduce tissue inflammation and may lessen the severity of swallowing difficulty. However, needle puncture is often not desired by patients. Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) is like acupuncture treatment, but the acupuncture points are stimulated with mild electrical stimulation without needles, simplifying treatment delivery. This study is to examine if a pre-selected set of acupuncture points treated using ALTENS can reduce swallowing difficulty. There will be a total of 12 treatments given over 6 to 8 weeks. Changes in severity of swallowing difficult after treatment will be assessed using 2 subjective assessment tools.
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
- •This study will recruit patients with head and neck cancers treated with radiation+/- chemotherapy and who meet the following criteria (EAT-10 assessment will be used for screening):
- •Inclusion Criteria
- •present with dysphagia symptoms
- •with no evidence of residue cancer
- •are within 3 months (but past 1 month) after treatment completion
- •show positive dysphagia (EAT-10 score of > 3) and/ or aspiration on barium swallow study
- •are over 18 years old
- •are able to read and write fluent English
- •can give informed consent
排除标准
- •have unstable heart disease
- •have infectious disease transmissible by blood or body fluid, including hepatitis and HIV
- •have skin disease at site of study acupuncture points that prevents the application of electrodes
结局指标
主要结局
Change in Subjective Dysphagia Assessment Score: EAT-10 from baseline
时间窗: 3 months after treatment completion
EAT-10 is a self-administered questionnaire for subjective assessment of dysphagia. It consists of 10 items and each item is scored using a 5-point Likert scale. The higher the point, the more severe the problem being scored. Normative data suggested that a total score of 3 or higher is abnormal.
次要结局
- Change in M. D. Anderson dysphagia inventory from baseline(3 months after treatment completion)
研究者
Raimond Wong
Associate Professor, Department of Oncology
McMaster University