A study to assess the Radiation dose to Dysphagia/Aspiration at Risk Structures(DARS) and its impact on quality of life in patients receiving hypo-fractionated RT in locally advanced Head and Neck Squamous cell Carcinoma (LA-HNSCC)
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Sparing of dysphagia aspiration associated risk structure,improved swallowing during and post treatment.
研究概览
简要总结
DARS structures (dysphagia and aspiration at risk) are the muscles which are directly involved in the act of swallowing,they are the pharyngeal constrictors(superior,middle,inferior)along with base of tongue muscle(cricopharyngeal)and esophageal inlet muscles. DuringRT(radiation therapy) to head and neck cancer patients ,these structures receive some amount of the dose throughout the treatment and hence the patient has symptoms of swallowing difficulty along with speech problems during and after treatment. Hence this study is going to elucidate the effectiveness of Hypo fractionated RT with respect to DARS sparing effect on swallowing apparatus, dysphagia and quality of life of patients with head and neck cancer. This study is going to be performed on 38patients with head and neck Squamous cell carcinoma between the year 2024 – 2026 and will be conducted at Yenepoya medical college and hospital with follow up for all patients during(weekly) and post treatment at 3months,6months and 12months respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants above 18 years of age diagnosed with head and neck cancer.
- •2.ECOG(Eastern Cooperative Oncology Group)status 0 or 1 will be taken.
- •3.Adult patients admitted with locally advanced biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx (stage II–IVA).
排除标准
- •1.Patients with tumors involving the thyroid, nasal cavity, nasopharynx and paranasal sinus are not eligible as confirmed by CECT /MRI / PET- CT findings and biopsy findings.
- •2.Patients with distant metastasis.
- •3.Patients who have received radiotherapy previously 4.Relapse/recurrence 5.Pregnant women.
- •6.Tracheostomized patient.
- •7.Body weight less than 30 kgs.
结局指标
主要结局
Sparing of dysphagia aspiration associated risk structure,improved swallowing during and post treatment.
时间窗: assessment shall be done on day of admission,3months,6months,1yr post completion of RT.
次要结局
- Hypofractionated schedule for treatment of head and neck cancer.(18 months)
研究者
Dr Bilita Kumari Parhi
yenepoya medical college