A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 119
- Locations
- 13
- Primary Endpoint
- Mucositis toxicity rates
Study Overview
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 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.
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 OBJECTIVES:
I. To record patient reported outcomes during radiotherapy. II. To evaluate patient narcotic use during radiotherapy. III. To evaluate the imaging and dosimetric differences in head and neck radiotherapy with and without a customized 3D printed oral stent.
OUTLINE: Patients are randomized to 1 of 2 arms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm I (3D printed oral stent)
Patients wear 3D printed oral stent during standard of care radiotherapy.
Intervention: Best Practice (Other)
Arm I (3D printed oral stent)
Patients wear 3D printed oral stent during standard of care radiotherapy.
Intervention: Medical Device Usage and Evaluation (Other)
Arm II (standard of care)
Patients receive standard of care during treatment.
Intervention: Best Practice (Other)
Arm II (standard of care)
Patients receive standard of care during treatment.
Intervention: Medical Device Usage and Evaluation (Other)
Outcomes
Primary Outcomes
Mucositis toxicity rates
Time Frame: Through study completion, an average of 1 year
Rate of non-target mucose will be estimated along with the corresponding 95% confidence interval. Cochran-Mantel-Haenszel (CHM) test will be applied to compare mucositis rates between the two treatment arms. Logistic regression will be used to compare occurrence of mucositis between two arms, adjusting for the effects of stratification factors as well as other covariates. T test or Wilcoxon rank sum test will be used to compare three Olerud-Molander Ankle Score between two arms: a mean mucositis score, an extent of mucositis score, and a worst site score.
Secondary Outcomes
- Patients narcotics diaries(Through study completion, an average of 1 year)
- Imaging difference(Through study completion, an average of 1 year)
- Composite pain scores(Through study completion, an average of 1 year)
- Dosimetric difference(Through study completion, an average of 1 year)
- Number of narcotic pills used(Through study completion, an average of 1 year)
- Patient reported outcomes(Through study completion, an average of 1 year)