NCT07227792Recruiting
Tongue-out Radiation Therapy (TORT) for the Mitigation of Radiotherapy-related Toxicities in Patients With Head and Neck Cancer
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 10 Nov 2025
- Start date
- 23 Nov 2025
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Yvonne Mowery
- Diseases
- Head and neck cancer
- NCT number
- NCT07227792
What you commit to
- Study type: Interventional
- Planned participants: 35
- From 23 Nov 2025 to the primary completion date, 30 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgical resection of the primary tumor
- Induction chemotherapy or immunotherapy prior to planned radiotherapy
- Prior head and neck radiotherapy
Other illness
- Patients with T1-T2 N0 glottic cancer (i.e., planned to undergo RT to the larynx only)
- Widely metastatic disease
Other
- Posterior pharyngeal wall primary tumor
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.