Tongue-out positioning to lower mouth and swallowing side effects in head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.