Actively Recruiting
A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents
Led by M.D. Anderson Cancer Center · Updated on 2026-04-15
119
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of customized three-dimensional (3D) printed oral stents in patients with head and neck cancers who are undergoing radiotherapy. The study aims to compare rates of mouth sores, called mucositis, in areas not targeted by radiation between patients who use these oral stents and those who receive standard care. This phase 2 trial also looks at patient-reported experiences, narcotic pain medication use, and imaging and radiation dose differences during treatment. Participants are randomly assigned to one of two groups. One group wears a customized 3D printed oral stent that fits over their teeth and gums during standard radiotherapy, while the other group receives only the standard radiotherapy without the stent. The oral stent is created from a mold of each patient's mouth and is designed to protect oral tissues during treatment. During the study, participants are monitored throughout their radiotherapy course, which lasts 5 to 7 weeks. Researchers collect data on mouth soreness, pain scores, narcotic use, and imaging studies to evaluate radiation effects. These outcomes are tracked for up to one year after treatment to assess the longer-term impact. Participants complete diaries and patient-reported outcome measures to provide detailed information on their symptoms and medication use.
CONDITIONS
Brief Title
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Performance Status of 0 to 2
- Participant will receive radiation alone or radiation with concurrent chemotherapy
- Signed study-specific consent form
You will not qualify if you...
- Prior head and neck radiotherapy
- Unable to fit a tongue-lateralizing or tongue-depressing stent
- Severe trismus with an incisal opening of less than 10 mm
- Inability to comply with study procedures
- Participants younger than 18 years
- Participants who are pregnant
- Cognitively impaired subjects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 5 to 7 weeks
Participants receive 5 to 7 weeks of head and neck radiotherapy either with a customized 3D printed oral stent or standard of care without the stent.
Radiotherapy visits according to standard care schedule
Duration - Up to 1 year
Participants are monitored for up to 1 year after radiotherapy to evaluate mucositis rates, patient reported outcomes, narcotic use, imaging, and dosimetric differences.
Periodic visits during the follow-up period
Trial Site Locations
Total: 7 locations
1
Banner Health/Banner Research
Phoenix, Arizona, United States, 85234
Actively Recruiting
2
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Actively Recruiting
3
Community MD Anderson Cancer Center East
Indianapolis, Indiana, United States, 46219
Actively Recruiting
4
Community MD Anderson Cancer Center South
Indianapolis, Indiana, United States, 46227
Actively Recruiting
5
Community MD Anderson Cancer Center North
Indianapolis, Indiana, United States, 46250
Actively Recruiting
6
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Actively Recruiting
7
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Anna Lee, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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