Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Launched by M.D. ANDERSON CANCER CENTER · Apr 30, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with head and neck cancers who are undergoing radiation therapy. The study focuses on using customized, 3D-printed oral stents, which are special devices made from a mold of a patient's mouth. These stents cover the teeth and gums during radiation treatment and may help reduce painful mouth blisters and sores that can often occur due to the therapy.

To be eligible for the trial, participants must be 18 years or older and are scheduled to receive 5 to 7 weeks of radiation therapy for their head and neck cancer. They may also receive chemotherapy along with the radiation. Participants will need to sign a consent form to join the study. It's important to note that individuals with a history of head and neck radiation, certain mouth issues, or those who are pregnant or cognitively impaired cannot participate. If you or a loved one meet the eligibility criteria, you may have the opportunity to help improve treatment for others by participating in this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• • Signed study-specific consent form
• Exclusion Criteria:
• • 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
• • Participants younger than 18 years of age
• • Participants must not be pregnant
• • Cognitively impaired subjects