A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Banner Health/Banner Research
RECRUITING
Phoenix
Florida
Baptist MD Anderson Cancer Center
RECRUITING
Jacksonville
Indiana
Community MD Anderson Cancer Center East
RECRUITING
Indianapolis
Community MD Anderson Cancer Center North
RECRUITING
Indianapolis
Community MD Anderson Cancer Center South
RECRUITING
Indianapolis
New Jersey
Cooper Hospital University Medical Center
RECRUITING
Camden
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Anna Lee, MD
alee13@mdanderson.org
932-750-1920
Time Frame
Start Date: 2021-05-26
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 119
Treatments
Experimental: Arm I (3D printed oral stent)
Patients wear 3D printed oral stent during standard of care radiotherapy.
Active_comparator: Arm II (standard of care)
Patients receive standard of care during treatment.
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov