An interventional study of standard radiotherapy and experimental radiotherapy in Oropharynx Cancer, Head and Neck Cancer and Xerostomia, sponsored by UNC Lineberger Comprehensive Cancer Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Prevention
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.
373 studies on the registry are indexed under Oropharyngeal Neoplasms; 97 are open to participants now.
Browse Oropharyngeal Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
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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
Standard radiotherapy planning aims to restrict the mean parotid radiation dose to less than or equal to 14 Gy.
Radiation: standard radiotherapy
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.
Radiation: experimental radiotherapy
radiotherapy planning goal is to restrict the mean parotid dose is equal to or less than 14Gy.
radiotherapy planning goal is to restrict the parotid duct dose is equal to or less than 14Gy
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.
Time frame: 6 months after completion of radiotherapy
Saliva mass
The mass of generated saliva post-radiation treatment will be measured.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months after completion of radiotherapy
Plan to share: No
This study is withdrawn, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center