Tongue-out Radiation Therapy (TORT) for the Mitigation of Radiotherapy-related Toxicities in Patients With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Eating Assessment Tool 10 (EAT-10)
研究概览
简要总结
Our institution recently began incorporating a novel "tongue-out" radiation therapy (TORT) technique for patients with head and neck tumors at particular subsites (oropharynx, larynx, hypopharynx). Protruding the tongue, i.e. "tongue-out" position, induces anatomical changes that facilitate decreased radiation dose to the oral tongue and PCM. The long-term goal is to determine whether TORT results in reduced severity and faster recovery from acute treatment-related toxicities (particularly mucositis, dysphagia, and dysgeusia) and improved long-term swallowing function and taste compared to traditional "tongue-in" RT for patients with HNC.
详细描述
Despite good disease control and organ preservation outcomes after radiotherapy (RT) for head and neck cancers (HNC), particularly human papillomavirus (HPV)-related oropharyngeal cancer, treatment-related toxicities remain a challenging survivorship problem. Impaired calorie intake due to common RT-associated toxicities such as mucositis, dysphagia (difficulty swallowing), and dysgeusia (taste loss) can lead to treatment breaks that reduce treatment efficacy and prolong recovery, some of which persist long-term and negatively impact quality of life (QOL). Radiation doses to the pharyngeal constrictor muscles (PCM) and oral tongue correlate with incidence and severity of dysphagia and dysgeusia. Doses to the pharyngeal and oral tongue mucosa are associated with incidence and severity of mucositis. "Tongue-out" radiation therapy (TORT) is a treatment positioning technique for patients with head and neck tumors at particular subsites (e.g., oropharynx, larynx, hypopharynx). Protruding the tongue, i.e. "tongue-out" position, during pre-treatment simulation and subsequent treatment induces anatomical changes that facilitate decreased radiation dose to the oral tongue and PCM. TORT for oropharyngeal, laryngeal, and hypopharyngeal cancers may result in significantly lower radiation dose to the PCM and oral tongue compared to "tongue-in" RT, and that this reduced dose to organs at risk (OARs) will yield clinically meaningful improvements in severity and duration of dysphagia, dysgeusia, and mucositis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (cT0-4, N0-3, M0-1).
- •Patients with metastatic disease will be included if the following criteria are met:
- •Definitive RT dose is planned for the primary site
- •The number of metastatic lesions is ≤5
- •All metastatic lesions are confined to a single organ (e.g., lung)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
- •Female subjects of childbearing potential must not be pregnant or breastfeeding at screening.
- •Female subjects are considered to be of childbearing potential unless one of the following criteria is met:
- •o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years-of-age in the absence of other biological or physiological causes. Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.
- •Female subjects of childbearing potential must utilize an appropriate method of birth control such as hormonal methods (oral, injectable, implant, skin patch, vaginal ring), intrauterine devices, barrier methods (consistent use of male/female condoms, diaphragms, cervical caps), surgical methods (vasectomy, tubal ligation), or true abstinence.
- •Must be able to comfortably protrude tongue in the treatment position for at least 1 minute.
- •Must have the ability to understand and the willingness to sign a written informed consent document.
- •Must be willing to comply with all study procedures.
- •Must be able to complete patient-reported outcome (PRO) questionnaires in English.
排除标准
- •Patients with T1-T2 N0 glottic cancer (i.e., planned to undergo RT to the larynx only)
- •Posterior pharyngeal wall primary tumor
- •Widely metastatic disease
- •Surgical resection of the primary tumor
- •Induction chemotherapy or immunotherapy prior to planned radiotherapy
- •Prior head and neck radiotherapy
结局指标
主要结局
Eating Assessment Tool 10 (EAT-10)
时间窗: At 6 weeks post-treatment
Mean difference in Eating Assessment Tool 10 (EAT-10) total scores between patients enrolled on this prospective study and matched retrospective controls. EAT-10 screens for dysphagia and aspiration risk. Total score ranges 0 - 40. Patients rate each question on a scale of 0 (no problem) to 4 (severe problem) regarding, weight loss, inability to go out for meals, increased swallowing effort, pain while swallowing, reduced pleasure while eating, bolus sensation, coughing, and stress when swallowing. Score of 15 or more means patient is at risk for aspiration. Follow up with a full dysphagia assessment and introduce safe swallowing strategies and a modified diet, as needed. Score of 16 or less means patient may not be at risk for aspiration and follow up with a full dysphagia assessment only if symptomatic.
次要结局
- Eating Assessment Tool 10 (EAT-10)(At 58 weeks post treatment)
- Change in Eating Assessment Tool 10 (EAT-10) Scores(At Baseline and 58 weeks post treatment)
- University of Washington Quality of Life Questionnaire (UW-QOL)(At 6 weeks post-treatment)
- Change in QoL per University of Washington Quality of Life Questionnaire (UW-QOL)(At Baseline and 6 weeks post-treatment)
- Difference in radiation doses - oral tongue(Up to 38 months)
- Difference in radiation doses - pharyngeal(Up to 38 moonths)
研究者
Yvonne Mowery
Associate Professor
University of Pittsburgh