Overview
This clinical trial studies the effect of customized 3 dimensional (3D) printed oral tents on patients with head and neck cancer who are receiving radiotherapy. Oral stents are made from the impression of patients' mouth and cover patients' teeth and gums during radiation therapy. A customized, 3D-printed oral stent may help to reduce mouth blisters and/or sores that may develop in patients while receiving head and neck radiation therapy.
Description
PRIMARY OBJECTIVE:
I. To evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3D printed oral stent.
SECONDARY OBJECTIVES:
I. To record patient reported outcomes during radiotherapy. II. To evaluate patient narcotic use during radiotherapy. III. To evaluate the imaging and dosimetric differences in head and neck radiotherapy with and without a customized 3D printed oral stent.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients wear 3D printed oral stent during standard of care radiotherapy.
ARM II: Patients receive standard of care during treatment.
Eligibility
Inclusion Criteria:
- Patient is dispositioned to receive definitive or adjuvant radiotherapy for treatment
of a diagnosed head and neck malignancy that includes
- Well lateralized tonsil cancer with no soft palate involvement and qualifies for ipsilateral radiotherapy
- Well lateralized buccal cancer that qualifies for ipsilateral radiotherapy
- Well lateralized parotid cancer that qualifies for ipsilateral radiotherapy
- A cancer that involves the nasal cavity and does not require coverage of the oral cavity or oropharynx
- A cancer that involves the maxillary sinus and does not require coverage of the
oral cavity or oropharynx
- A cancer that involves the base of tongue
- Age 18 or older
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- The patient will receive radiotherapy with either cisplatin, carboplatin, or cetuximab
- Signed study-specific consent form
Exclusion Criteria:
- Prior head and neck radiotherapy
- Patient is unable to fit a tongue-lateralizing or tongue-depressing stent
- Severe trismus with an incisal opening of < 10 mm
- Inability to comply with the study procedures
- Patients younger than 18 years of age
- Patients must not be pregnant