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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-03221 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-1153 | Other Identifier | M D Anderson Cancer Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (3D printed oral stent) | Experimental | Patients wear 3D printed oral stent during standard of care radiotherapy. |
|
| Arm II (standard of care) | Active Comparator | Patients receive standard of care during treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard of care |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Lee, MD | Contact | 932-750-1920 | alee13@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Anna Lee | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Health/Banner Research | Recruiting | Phoenix | Arizona | 85234 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Medical Device Usage and Evaluation | Other | Wear 3D printed oral stent |
|
| 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 |
| Baptist MD Anderson Cancer Center | Recruiting | Jacksonville | Florida | 32207 | United States |
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| Community MD Anderson Cancer Center East | Recruiting | Indianapolis | Indiana | 46219 | United States |
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| Community MD Anderson Cancer Center South | Recruiting | Indianapolis | Indiana | 46227 | United States |
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| Community MD Anderson Cancer Center North | Recruiting | Indianapolis | Indiana | 46250 | United States |
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| Cooper Hospital University Medical Center | Recruiting | Camden | New Jersey | 08103 | United States |
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| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D010307 | Parotid Neoplasms |
| D008444 | Maxillary Sinus Neoplasms |
| D009062 | Mouth Neoplasms |
| D014062 | Tongue Neoplasms |
| D014067 | Tonsillar Neoplasms |
| ID | Term |
|---|---|
| D012468 | Salivary Gland Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D010255 | Paranasal Sinus Neoplasms |
| D009669 | Nose Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010254 | Paranasal Sinus Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
| D014060 | Tongue Diseases |
| D009959 | Oropharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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