Efficacy of Acupuncture in Radiotherapy-induced Dysphagia in Patients With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 4.
研究概览
简要总结
Purpose:
Rationale: Acupuncture is a therapy for physical activity disorders secondary to nervous diseases, and it may have therapeutic effects on dysphagia caused by radiation therapy.
Purpose: This randomized trial aims to investigate whether acupuncture may alleviate radiation-induced dysphagia in patients with head and neck cancer. The effect was compared with outcomes in patients without receiving acupuncture.
详细描述
OBJECTIVE
Primary:
To determine the therapeutic efficacy of acupuncture on radiotherapy-induced dysphagia in patients with head and neck cancer.
Secondary:
- To determine whether acupuncture can improve swallow function in these patients.
- To determine what extent acupuncture can improve the complications of dysphagia of these patients, including the incidence of aspiration pneumonia, malnutrition.
- To determine what extent this traditional Chinese therapy can improve quality of life of these patients.
- To evaluate the safety of acupuncture in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes, inclduing VDS, rosenbek Penetration-Aspiration Scale scores, opening of upper esophageal sphincter(UES) and excursion of hyoid bone would be evaluated by two radiologists with blind method.
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
- •Patients must have received radiation therapy for histologically confirmed head and neck cancer;
- •Prior irradiation >/= 6 months prior to study entry;
- •Age>/= 18 years;
- •Routine laboratory studies with bilirubin </=2 * upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) < 2 * ULN, creatinine <1.5 * ULN, red-cell count >/= 4,000 per cubic millimeter; white-cell count >/=1500 per cubic millimeter, platelets >/= 75,000 per cubic millimeter; PT, APTT, INR in a normal range;
- •Ability to understand and willingness to sign a written informed consent document, or constant caregivers who well understand and willingness to sign a written informed consent document.
排除标准
- •Evidence of metastatic disease or tumor recurrence, tumor invasion to major vessels (e.g. the carotid);
- •Evidence of very high intracranial pressure that suggests brain hernia and need surgery;
- •History of seizures or bleeding related to tumor or radiotherapy during or after the completion of radiation;
- •History of coagulation defects or allergy history of contrast agent;
- •History of disorder that affects swallowing, including brain stroke, oral or throat disease, malignances diseases, infection of the nervous system, demyelinating disease, neurodegenerative disease, advanced dementia, diabetes, peripheral vascular disease, HIV infection, familial degenerative peripheral neuropathy;
- •Severe complications: 1) New York heart association grade II or greater congestive heart failure; 2) Serious and inadequately controlled cardiac arrhythmia; 3) Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection); 4) Clinically significant peripheral vascular disease; 5) significant uncontrolled life-threatening infection;
- •Prior use of acupuncture for dysphagia;
- •Enrolled in other clinical trials.
结局指标
主要结局
The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 4.
时间窗: Assessed at baseline and week 4 during acupuncture treatment.
The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 4. VDS, according to result of Video Fluoroscopy Swallowing Study (VFSS), used as an objective and quantifiable predictor of recovery of the swallowing function. A videofluoroscopic dysphagia scale (VDS) with a sum of 100 was made according to the odds ratios of prognostic factors. The validity of the scale was evaluated by using a receiver operating characteristic curve. The VDS was compiled using the following 14 items: lip closure, bolus formation, mastication, apraxia, tongue-to-palate contact, premature bolus loss, oral transit time, triggering of pharyngeal swallow, vallecular residue, laryngeal elevation, pyriform sinus residue, coating of pharyngeal wall, pharyngeal transit time, and aspiration. At a scale cutoff value of 47. The higher the VDS score, the worse the swallowing function.
次要结局
- The change of nutritional status from baseline to week 4 and week 16.(Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.)
- The percentage of necessary of nasogastric feeding and gastrostomy from baseline to week 16.(Assessed at baseline and 12 weeks post acupuncture treatment.)
- The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 16.(Assessed at baseline and 12 weeks post acupuncture treatment.)
- The change of rosenbek Penetration-Aspiration Scale scores, opening of upper esophageal sphincter(UES) and excursion of hyoid bone from baseline to week 4 and week 16.(Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.)
- The incidence of aspiration pneumonia change from baseline to week 4 and week 16.(Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.)
- The change of Quality of Life (QOL) scores from baseline to week 4 and week 16.(Assessed at baseline, week 4 during acupuncture treatment and 12 weeks post acupuncture treatment.)
研究者
Yamei Tang
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University