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Tongue-out Radiation Therapy (TORT) for Head and Neck Cancer

This study is looking at a new way to give radiation therapy (RT) called "Tongue-out Radiation Therapy" (TORT) for people with head and neck cancer. TORT involves holding your tongue out during treatment, which may help reduce the amount of radiation that reaches your tongue and other swallowing muscles. Researchers want to see if TORT can lessen common side effects like mouth sores (mucositis), trouble swallowing (dysphagia), and changes in taste (dysgeusia), and help you recover faster. You might be able to join if you have squamous cell carcinoma of the oropharynx, larynx, or hypopharynx, are 18 or older, and meet other specific criteria. The study will measure how well you can eat at the start and 6 weeks after treatment to see if TORT helps.

Study design
This is an interventional study with a planned enrollment of 35 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your eating ability will be measured at the start of treatment and again 6 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07227792

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

Recruiting
NAAges 18+InterventionalTreatment
Yvonne Mowery
~35 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Tongue-out radiation therapy (TORT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Eating Assessment Tool 10 (EAT-10)
Measured over At Baseline
+1 more outcome measured

Conditions

Head and Neck Carcinoma

Explore related trials

Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaOropharyngeal Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Yvonne Mowery, MD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center

Who to contact

Samantha Demko, RN
[email protected]
412-623-1400
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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.

What this trial measures

  • Eating Assessment Tool 10 (EAT-10)At Baseline

    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.

  • Eating Assessment Tool 10 (EAT-10)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.