About this trial

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.

Eligibility criteria

Qualifiers

Participant is dispositioned to receive 5-7 weeks of definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy

Age 18 or older

ECOG PS 0-2

The participant will receive either (a) radiation alone or (b) radiation with concurrent chemotherapy of any kind(s)

Disqualifiers

Prior head and neck radiotherapy

Participants 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

Trial design

Treatments tested in this trial

  • Best Practice
  • Medical Device Usage and Evaluation

Treatment groups

119 Participants
are divided into 2 treatment groups

Locations

7
Banner Health/Banner Research85234, PhoenixArizona, United States
Baptist MD Anderson Cancer Center32207, JacksonvilleFlorida, United States
Community MD Anderson Cancer Center East46219, IndianapolisIndiana, United States
Community MD Anderson Cancer Center North46250, IndianapolisIndiana, United States

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor