Tongue-out Radiation Therapy (TORT) for the Mitigation of Radiotherapy-related Toxicities in Patients With Head and Neck Cancer

Inclusion Criteria

• •1. Must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (cT0-4, N0-3, M0-1).
• •2. 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)
• •3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
• •4. 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.
• •5. Must be able to comfortably protrude tongue in the treatment position for at least 1 minute.
• •6. Must have the ability to understand and the willingness to sign a written informed consent document.
• •7. Must be willing to comply with all study procedures.
• •8. Must be able to complete patient-reported outcome (PRO) questionnaires in English.