The Impact of Swallowing and Nutrition in Head and Neck Cancer Patients Undergoing Chemo or Chemo-radiotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- hypopharyngeal mean peak pressure
研究概览
简要总结
This study focuses on swallowing dysfunction, a common issue affecting 60-75% of head and neck cancer patients due to tumor damage, treatment complications, and chemoradiotherapy side effects, which can lead to malnutrition and reduced quality of life. With limited research on the effects of radiation doses on swallowing muscles and nutrition, this study aims to evaluate these impacts in non-surgical patients undergoing radiotherapy, conducting assessments before treatment, three months after, and within one year post-treatment.
详细描述
Swallowing dysfunction is a common and debilitating symptom in head and neck cancer patients, affecting approximately 60-75% during the disease course, primarily due to tumor destruction, postoperative complications, and side effects of radiotherapy and chemotherapy. Combined chemoradiotherapy exacerbates adverse effects, such as mucositis, odynophagia, taste alterations, xerostomia, nausea, vomiting, and fatigue, which can result in dehydration, significant weight loss, and detrimental impacts on nutritional status, functionality, and quality of life. Limited research exists on the effects of radiation and chemoradiation doses on swallowing muscles, quality of life, and nutritional changes in these patients. This study aims to evaluate the impact of radiation doses on swallowing muscles and quality of life in head and neck cancer patients undergoing chemoradiotherapy while identifying malnutrition risk in this population. Non-surgical patients receiving radiotherapy as the primary treatment will be recruited, with swallowing, muscle, and nutritional assessments conducted before treatment, three months after treatment, and within one year post-treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo radiotherapy or concurrent chemoradiotherapy ;
- •Aged between 18 and 80 years;
- •Able to perform self-care independently (ECOG ≤ 2);
- •All patients provide written informed consent.
排除标准
- •Patients scheduled to undergo surgical treatment;
- •Patients with neuromuscular diseases, such as stroke or Parkinson's disease;
- •Patients with other diseases or complications, including heart disease classified as NYHA functional class ≥ 2 with thrombotic conditions, or lung disease classified as Hugh-Jones grade ≥ 4;
- •Patients with psychological disorders that may affect their ability to provide informed consent or comply with the study protocol;
- •Patients who do not consent to undergo high-resolution impedance manometry.
结局指标
主要结局
hypopharyngeal mean peak pressure
时间窗: one year
hypopharyngeal contraction
次要结局
未报告次要终点
研究者
National Taiwan University Clinical Trial Center
Attending Anesthesiologist
National Taiwan University Hospital