Tongue-out positioning to lower mouth and swallowing side effects in head and neck cancer
Tongue-out Radiation Therapy (TORT) for the Mitigation of Radiotherapy-related Toxicities in Patients With Head and Neck Cancer
This trial will try a 'tongue-out' position during radiation to see if it lowers mouth sores, taste changes, and swallowing problems for people with oropharyngeal, laryngeal, or hypopharyngeal squamous cell carcinoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07227792 on ClinicalTrials.gov |
What this trial studies
Tongue-out radiation therapy (TORT) uses tongue protrusion during CT simulation and each treatment session to shift anatomy and reduce radiation dose to the oral tongue and pharyngeal constrictor muscles. Patients with oropharyngeal, laryngeal, or hypopharyngeal squamous cell carcinoma receive IMRT or VMAT planned with the tongue-out position. The study records dosimetric endpoints (dose to oral tongue and PCM) and clinical outcomes including acute mucositis, dysphagia, dysgeusia, and longer-term swallowing and taste recovery. Outcomes will be compared to conventional tongue-in positioning or institutional benchmarks to see if TORT shortens toxicity duration and lessens severity.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (cT0-4, N0-3, M0-1) who are planned for definitive radiotherapy and have ECOG performance status 0–2.
Not a fit: Patients with tumors outside the oropharynx/larynx/hypopharynx, those unable to safely protrude their tongue, or those not receiving definitive radiation (for example, diffuse metastatic disease) are unlikely to benefit.
Why it matters
Potential benefit: If successful, TORT could reduce the severity and duration of mouth sores, taste loss, and swallowing problems and improve long-term quality of life for affected patients.
How similar studies have performed: The TORT positioning technique is relatively novel with mostly dosimetric and early feasibility data reported and limited large clinical outcome evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Exclusion Criteria:
1. Patients with T1-T2 N0 glottic cancer (i.e., planned to undergo RT to the larynx only)
2. Posterior pharyngeal wall primary tumor
3. Widely metastatic disease
4. Surgical resection of the primary tumor
5. Induction chemotherapy or immunotherapy prior to planned radiotherapy
6. Prior head and neck radiotherapy
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Yvonne Mowery, MD — UPMC Hillman Cancer Center
- Study coordinator: Samantha Demko, RN
- Email: albesl@upmc.edu
- Phone: 412-623-1400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.