Status:
RECRUITING
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Head and Neck Carcinoma
Malignant Parotid Gland Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 impressio...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3D printed oral stent. SECONDARY OBJECTI...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT04870762
Start Date
May 26 2021
End Date
December 31 2026
Last Update
October 8 2025
Active Locations (7)
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1
Banner Health/Banner Research
Phoenix, Arizona, United States, 85234
2
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
3
Community MD Anderson Cancer Center East
Indianapolis, Indiana, United States, 46219
4
Community MD Anderson Cancer Center South
Indianapolis, Indiana, United States, 46227