RecruitingPhase 2

Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

United States119 participantsStarted 2021-05-26

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mucositis toxicity rates

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT04870762

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Anna Lee, MD

932-750-1920 alee13@mdanderson.org

View on ClinicalTrials.gov More Head and Neck Carcinoma trials