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Operational reason
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Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment.
This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mean Parotid | Active Comparator | Standard radiotherapy planning aims to restrict the mean parotid radiation dose to less than or equal to 14 Gy. |
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| Parotid Duct | Experimental | Magnetic resonance images will be used to localize the parotid ducts and limit the radiation dose to these structures to less than or equal to 14 Gy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard radiotherapy | Radiation | radiotherapy planning goal is to restrict the mean parotid dose is equal to or less than 14Gy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference in patient-reported xerostomia 6 months | The difference in patient-reported xerostomia will be assessed using the MD Anderson Symptom Inventory -Head & Neck (MDASI-HN) questionnaire. MDASI multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Use the MDASI to assess the severity of symptoms Each question is scaled from 0 to 10. 0= not present and 10= as bad as you imagine. | 6 months after completion of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Saliva mass | The mass of generated saliva post-radiation treatment will be measured. | 6 months and 12 months after completion of radiotherapy |
| Parotid duct dose constraint | The efficacy of 14Gy parotid duct constraint for subjects undergoing parotid ductal sparing radiation therapy will be measured using patient-reported xerostomia scores. |
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In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained up for the subject to be considered eligible for treatment.
Inclusion Criteria
5 No contraindications to receiving MRI such as implanted electrical devices, pregnancy, and significant quantities of metal in the head/neck
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Colette Shen, MD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill, Department of Radiation Oncology | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials | View source |
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| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| experimental radiotherapy | Radiation | radiotherapy planning goal is to restrict the parotid duct dose is equal to or less than 14Gy |
|
| 6 months after completion of radiotherapy |
| The difference in patient-reported xerostomia 12 months | The difference in patient-reported xerostomia will be assessed using the MD Anderson Symptom Inventory -Head & Neck (MDASI-HN) questionnaire. MDASI multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Each question is scaled from 0 to 10. 0= not present and 10= as bad as you imagine. | 12 months after completion of radiotherapy |
| Xerostomia by NCI-CTCAE | xerostomia will be assessed using The National Cancer Institute Common Terminology Criteria for Adverse Events is a descriptive terminology (NCI-CTCAE) v5.0 that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | 12 months after completion of radiotherapy |
| D010608 |
| Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |