Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Study Overview
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Brief Summary
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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
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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. ARM I: Patients wear 3D printed oral stent during standard of care radiotherapy. ARM II: Patients receive standard of care during treatment.

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

Conditions
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Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm, Maxillary Sinus Carcinoma, Nasal Cavity Carcinoma, Oral Cavity Carcinoma, Tongue Carcinoma, Tonsillar Carcinoma

Intervention / Treatment
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* Other: Best Practice
* Other: Medical Device Usage and Evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is dispositioned to receive definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy that includes Well lateralized tonsil cancer with no soft palate involvement and qualifies for ipsilateral radiotherapy Well lateralized buccal cancer that qualifies for ipsilateral radiotherapy Well lateralized parotid cancer that qualifies for ipsilateral radiotherapy A cancer that involves the nasal cavity and does not require coverage of the oral cavity or oropharynx A cancer that involves the maxillary sinus and does not require coverage of the oral cavity or oropharynx A cancer that involves the base of tongue Age 18 or older Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 The patient will receive radiotherapy with either cisplatin, carboplatin, or cetuximab Signed study-specific consent form Exclusion Criteria: Prior head and neck radiotherapy Patient 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 Patients younger than 18 years of age Patients must not be pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (3D printed oral stent)<br>Patients wear 3D printed oral stent during standard of care radiotherapy. | Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Other: Medical Device Usage and Evaluation<br>* Wear 3D printed oral stent<br>|
| Active Comparator: Arm II (standard of care)<br>Patients receive standard of care during treatment. | Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Other: Medical Device Usage and Evaluation<br>* Wear 3D printed oral stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucositis toxicity rates | 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. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes | Will be assessed using the MD Anderson Symptom Inventory Head and Neck questionnaire. T test or Wilcoxon rank sum test will be used to compare scores of each item per time point or sums of scores across all items at each time point or sums across three time point per item between the two arms. Multivariate analyses such as linear regression model adjusting for the effects of covariates might be performed to compare patients reported outcomes. Appropriate data transformation will be performed if necessary for assumption of normality. | Through study completion, an average of 1 year | 
| Patients narcotics diaries | Will record the worst, the least, the average pain score and pain score at present for each day. Will calculate the average of these 4 scores as a composite daily pain score. | Through study completion, an average of 1 year | 
| Imaging difference | The set up error during radiation will be measured in each treatment arm. | Through study completion, an average of 1 year | 
| Dosimetric difference | The radiation dose to healthy tissue will be measured in each treatment arm. | Through study completion, an average of 1 year | 
| Composite pain scores | An area under curve of pain scores over two weeks (AUC2wks) will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms. The linear mixed models will also be fitted to evaluate the association of composite pain scores with occurrence of their non-target mucosa. | Through study completion, an average of 1 year | 
| Number of narcotic pills used | An AUC2wks will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms. | Through study completion, an average of 1 year |