This phase II 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04870762.
PRIMARY OBJECTIVE:
I. To evaluate physician-assessed mucositis rates in non-target mucosa of patients who receive head and neck radiation.
II. To measure patient reported outcomes (PROs) in these patients with or without a customized 3D printed oral stent.
SECONDARY OBJECTIVES:
I. To evaluate patient narcotic use during and post radiotherapy.
II. To evaluate the imaging and dosimetric differences between the arms of the study
III. To record treatment disruptions in the two arms for any reason
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.
Lead OrganizationUT MD Anderson Cancer Center
Principal InvestigatorAnna Lee
