Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07227792

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

Led by Yvonne Mowery · Updated on 2025-12-17

35

Participants Needed

1

Research Sites

166 weeks

Total Duration

On this page

Sponsors

Y

Yvonne Mowery

Lead Sponsor

R

Radiological Society of North America

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (cT0-4, N0-3, M0-1)
  • If metastatic disease is present, definitive radiotherapy is planned for the primary site
  • Number of metastatic lesions is 5 or fewer, all confined to a single organ
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Female participants of childbearing potential are not pregnant or breastfeeding at screening
  • Female participants of childbearing potential use appropriate birth control methods
  • Ability to comfortably protrude the tongue in the treatment position for at least 1 minute
  • Ability to understand and willingness to sign informed consent
  • Willingness to comply with all study procedures
  • Ability to complete patient-reported outcome questionnaires in English
Not Eligible

You will not qualify if you...

  • Patients with T1-T2 N0 glottic cancer planned for radiotherapy to the larynx only
  • Primary tumor on the posterior pharyngeal wall
  • Widely metastatic disease
  • Surgical removal of the primary tumor prior to study
  • Induction chemotherapy or immunotherapy before planned radiotherapy
  • Prior head and neck radiotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

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Research Team

S

Samantha Demko, RN

CONTACT

B

Brieanna Marino, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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