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

NCT07227792 | Recruiting DMC FDA Device

• 1 other identifier: HCC 25-085
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Carcinoma

Keywords

Tongue-out radiation therapy (TORT); human papillomavirus (HPV)-related oropharyngeal cancer; Intensity modulated radiotherapy (IMRT); volumetric modulated arc therapy (VMAT)

Outcome Measures

Primary Outcomes (2)

• Eating Assessment Tool 10 (EAT-10)

  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.

  At Baseline

• Eating Assessment Tool 10 (EAT-10)

  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.

  At 6 weeks post-treatment

Secondary Outcomes (7)

• Eating Assessment Tool 10 (EAT-10)

  At 58 weeks post treatment

• Change in Eating Assessment Tool 10 (EAT-10) Scores

  At Baseline and 6 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

Study Arms (1)

Tongue-out radiation therapy (TORT)

EXPERIMENTAL

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. All patients will be treated with IMRT. All IMRT techniques, including static field IMRT, helical IMRT (Tomotherapy), and VMAT are allowed.

Radiation: Tongue-out radiation therapy (TORT)

Interventions

Tongue-out radiation therapy (TORT) RADIATION

The high-risk PTV will contain the primary tumor and any lymph nodes confirmed or suspected to harbor metastatic disease based on imaging findings, pathology reports, and/or clinical exam. Dose to the high-risk PTV must be 70.0 Gy at 2.0 Gy per fraction. The intermediate-risk PTV will contain areas considered to contain potential microscopic disease in close proximity to the primary tumor (GTV + 10 mm with adjustments per above based on anatomic boundaries or air) and the entire cervical lymph node level(s) corresponding to any lymph nodes confirmed or suspected to harbor metastatic disease. Dose to intermediate-risk PTV must be 63 Gy at 1.8 Gy per fraction. The low-risk PTV will contain any cervical lymph node levels felt to be potentially harbor microscopic disease but with negative imaging and/or clinical findings. The exact cervical lymph node levels included in the low-risk PTV should be based on Tables 3-5. Dose to the low-risk PTV must be 56 Gy at 1.6 Gy per fraction.

Tongue-out radiation therapy (TORT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yvonne Mowery: lead
• Radiological Society of North America: collaborator

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Study Officials

• Yvonne Mowery, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Demko, RN

CONTACT

412-623-1400; albesl@upmc.edu

Brieanna Marino, MS

CONTACT

4126478258; rowlesbm@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 13, 2025
• Study Start: November 23, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): January 31, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)