Randomized Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- The difference in patient-reported xerostomia 6 months
研究概览
简要总结
Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment.
This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
The difference in patient-reported xerostomia 6 months
时间窗: 6 months after completion of radiotherapy
The difference in patient-reported xerostomia will be assessed using the MD Anderson Symptom Inventory -Head \& Neck (MDASI-HN) questionnaire. MDASI multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Use the MDASI to assess the severity of symptoms Each question is scaled from 0 to 10. 0= not present and 10= as bad as you imagine.
次要结局
- Saliva mass(6 months and 12 months after completion of radiotherapy)
- Parotid duct dose constraint(6 months after completion of radiotherapy)
- The difference in patient-reported xerostomia 12 months(12 months after completion of radiotherapy)
- Xerostomia by NCI-CTCAE(12 months after completion of radiotherapy)
