A Phase 2 interventional study of Best Practice and Medical Device Usage and Evaluation in Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm and Maxillary Sinus Carcinoma, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
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.
27 studies on the registry are indexed under Parotid Neoplasms; 7 are open to participants now.
This study's enrollment of 88 is above the median of 55 across 20 interventional studies indexed under Parotid Neoplasms.
Browse Parotid Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients wear 3D printed oral stent during standard of care radiotherapy.
Other: Best Practice · Other: Medical Device Usage and Evaluation
Patients receive standard of care during treatment.
Other: Best Practice · Other: Medical Device Usage and Evaluation
Receive standard of care
Also known as: standard of care, standard therapy
Wear 3D printed oral stent
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.
Time frame: Through study completion, an average of 1 year
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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
Imaging difference
The set up error during radiation will be measured in each treatment arm.
Time frame: Through study completion, an average of 1 year
Dosimetric difference
The radiation dose to healthy tissue will be measured in each treatment arm.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center