Acute and long term impact of head and neck cancer treatment on autonomic function
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- All India Institute Of Medical Sciences, New Delhi
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Autonomic Function Tests
概览
简要总结
Multimodality treatment for head and neck cancer involves surgery followed by adjuvant treatment. Surgery includes wide excision of the primary tumor along with lymph nodal clearance. Head and neck is an anatomically complex region with numerous neurovascular structures located in close proximity like vagus nerve, sympathetic chain carotid bulb and baroreceptors which are important for cardiovascular autonomic control. Depending on the disease extension and need to obtain oncological clear margins, these structures may sustain varying degrees of deficit during neck dissection. Adjuvant radiation in the post op settings which usually causes intimal thickening, perivascular fibrosis and obliterative endarteritis could also lead to their temporary or permanent damage. This could manifest as orthostatic intolerance, labile blood pressure and blood pressure fluctuations. It is therefore crucial to evaluate the extent of autonomic dysfunction in these patients and to understand its mechanism to effectively manage and halt cardiovascular comorbidity from developing in future.
A prospective analysis will be conducted at a tertiary cancer care center over a period of 2 years. All head and neck cancer patients who have been planned to be treated by surgery followed by adjuvant
radiotherapy and are satisfying the inclusion and exclusion criteria will be included in the study. All patients will be evaluated clinic-radiologically for confirming the stage of the disease.
After taking informed consent, they will undergo the following assessments at the below mentioned time points: 1. Autonomic function test which includes heart rate variability, deep breathing test, head up tilt test and hand grip test( Preoperative, 4 weeks post-surgery, 3 months post adjuvant radiation and 1 year post completion of treatment). 2. Ultrasound doppler of the carotid artery done at baseline and 1 year from start of treatment. Parameters to be assessed on ultrasound would be Intimal thickening, Presence of atheromatous plaque, Luminal narrowing, Presence of critical stenosis. 3. The fibrofatty tissue in the carotid triangle
would be sent for histopathological analysis to determine the lymph node yield.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with histologically proven head and neck cancer planned for curative intent treatment.
- •The treatment plan should include surgery and adjuvant treatment
- •Surgical intervention should include neck dissection.
排除标准
- •Previously Known Hypertensive
- •Previously Known Diabetics
- •Comorbid illnesses with possibility of autonomic dysfunction- Parkinson’s Disease
- •Patient demonstrating local or loco- regional recurrent disease in close proximity of critical neuro-vascular structures during follow-up AFT assessment
- •Patients post total laryngectomy.
结局指标
主要结局
1. Autonomic Function Tests
时间窗: Both will be assessed at | Baseline, 4 weeks, 12 weeks, 1 year
2. Carotid artery intimal thickening
时间窗: Both will be assessed at | Baseline, 4 weeks, 12 weeks, 1 year
次要结局
- 1. To determine extent of dysfunction for various components of Autonomic Function Tests(2. To determine the incidence and extent of intimal thickening, luminal narrowing and critical stenosis in the region of carotid sinus on ultrasound doppler performed at 1 year from the day of surgery)
研究者
Mridul Rathi
All India Institute Of Medical Sciences, New Delhi