Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients Undergoing Radiotherapy: a Randomized Controlled Trial of Swallowing Therapy"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Oropharyngeal muscle volume and signal intensity measured by T2 weighted MRI
研究概览
简要总结
Swallowing dysfunction after chemo-radiation is common, but there is no reliable evidence for how it should be managed. This pilot randomized controlled trial evaluated the relative benefit of a battery of isometric / isotonic exercises on the maintenance of muscle composition and function for swallowing in Head / Neck Cancer patients undergoing chemo-radiation therapy.
详细描述
Swallowing deficits resulting from oropharyngeal cancer and the ablative therapies used to control the disease are often devastating to the functional feeding outcome in these patients. Most patients will experience some degree of dysphagia along with nutritional decline. In particular, the swallowing outcome of those patients treated with external beam radiation is suggested to be poorer than those patients treated by surgical interventions alone. It has also been postulated that the formation of radiation-induced fibrotic tissue, along with the acute radiation effects (edema, mucositis, xerostomia) may act collectively to promote muscular disuse or atrophy, and the noted decline in swallowing function. We therefore suggest that a program of swallowing exercises may help facilitate and maintain muscle function in the oral cavity and pharynx during radiotherapy, thus preserving or supporting swallowing function in these patients.
This study will follow a randomized controlled trial design. Patients with confirmed head / neck cancer identified for planned radiotherapy will undergo a baseline evaluation including clinical and instrumental swallowing assessment, nutritional examination, and MRI prior to CRT. Subjects will then be randomized to one of three intervention arms representing control, placebo and intervention groups. Patients will be treated for 6 weeks and progress reassessed at 6 months. Outcome assessment will be completed by a blinded observer. Primary outcomes include; I)Oropharyngeal active muscle volume, signal intensity, and tissue composition over time as identified by T2 weighted MRI, II)Level of functional swallowing ability,III)Patient perception of swallowing function and quality of life.The results of the study will provide information on the efficacy (or lack of efficacy) of isometric / isotonic exercises for the maintenance of swallowing function post radiotherapy for Head /Neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Head / neck cancer of the oropharyngeal or adjacent regions, confirmed by clinical history and exam, with positive cross sectional imaging studies and histopathological biopsy excluding other pathology.
- •Planned to undergo external beam radiation therapy,
- •No previous history of nonoral feeding for cancer related illness,
- •Able to undergo MRI procedures.
- •Physician / patient agreement to participate
排除标准
- •Planned surgical intervention
- •Existence of a co-existing neurological or medical disorder known to cause dysphagia
- •Prior radiotherapy or surgery to the head / neck region that could contribute to dysphagia.
- •Previous swallowing therapy within four weeks of randomization
结局指标
主要结局
Oropharyngeal muscle volume and signal intensity measured by T2 weighted MRI
时间窗: Baseline, 6 weeks( end of CRT), 6 months(following CRT)
Level of functional swallowing ability- measured by functional eating score (FOIS), clinical swallowing score, videoendoscopy and videofluoroscopic evaluation
时间窗: Baseline, 6 week(end of CRT), 6 months(following CRT)
Patient perception of swallowing ability
时间窗: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Quality of Life
时间窗: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
次要结局
- Taste perception(Baseline, 6 weeks (end of CRT), 6 months (following CRT))
- Perception of smell(Baseline, 6 weeks (end of CRT), 6 months (following CRT))
- Salivation rates(Baseline, 6 weeks (end of CRT), 6 months (following CRT))