Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Recruiting
Phase 2
Interventional Study
Head and Neck Carcinoma
Malignant Parotid Gland Neoplasm
Maxillary Sinus Carcinoma
Nasal Cavity Carcinoma
Oral Cavity Carcinoma
Tongue Carcinoma
Tonsillar Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 119 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Other
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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 …
Trial Locations
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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 chemotherap…
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