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
- 1
- 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
- •In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained up for the subject to be considered eligible for treatment.
- •Inclusion Criteria
- •Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
- •Subjects is willing and able to comply with study procedures based on the judgment of the investigator.
- •Age ≥ 18 years at the time of consent.
- •T0-4, N0-3, M0 disease American Joint Committee on Cancer (AJCC 7th or 8th edition) of the oropharynx (this includes patients with head and neck cancer of unknown primary origin, often categorized as T0 disease, who will be treated with radiotherapy to the oropharynx) planned for definitive radiotherapy +/- chemotherapy
- •5 No contraindications to receiving MRI such as implanted electrical devices, pregnancy, and significant quantities of metal in the head/neck
排除标准
- •Patients with Sjogren's syndrome or baseline xerostomia (CTCAE > 0 for the question regarding dry mouth)
- •Patients with lesions grossly involving the salivary glands
- •Patients with an allergy to lemon juice
- •Prior history of radiation therapy to the head and neck
研究组 & 干预措施
Mean Parotid
Standard radiotherapy planning aims to restrict the mean parotid radiation dose to less than or equal to 14 Gy.
干预措施: standard radiotherapy (Radiation)
Parotid Duct
Magnetic resonance images will be used to localize the parotid ducts and limit the radiation dose to these structures to less than or equal to 14 Gy.
干预措施: experimental radiotherapy (Radiation)
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)