An interventional study of Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography in Head and Neck Cancer, Oropharynx Cancer and Xerostomia Due to Radiotherapy, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-31.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Treatment
The proposed study is an attempt to improve patient xerostomia (dry mouth) after definitive radiation therapy treatment for head and neck cancer. Xerostomia is a frequently experienced symptom for those receiving radiation therapies to the head and neck that persists after treatment, potentially indefinitely. It has been shown that stem/progenitor cells preferentially reside in large ducts of salivary glands and that these cells have the ability to repair radiation induced salivary damage. Current practice does not specifically attempt to spare these regions and considers the entire salivary gland to have equal importance and function. This study will involve the acquisition of pre-treatment MRI sialogram images which enable visualization of salivary ducts (using saliva itself as a contrast agent) that can then be avoided during radiation treatment planning. Saliva samples will also be collected at this time to quantify baseline saliva secretion and saliva characteristics. The primary objective will be to obtain patient reported outcomes (PRO) measure of xerostomia related symptoms for comparison with a historical cohort. Xerostomia symptom information will be obtained by use of a patient reported quality of life survey administered prior to treatment and at 6, 12, 18, and 24 months after treatment. The secondary objectives will be to quantitatively assess post-treatment changes in saliva secretion, salivary gland volume, and ductal visibility using MRI sialograms. The target sample size for this study is 40 patients. The investigator hypothesizes that reducing the dose to these stem cell containing salivary ducts will facilitate improvements in patient reported symptoms as well as improved recovery of salivary secretion, salivary gland volume, and intra-glandular ductal visibility using MRI sialograms.
Exclusion Criteria:
Patients with Oropharyngeal Squamous Cell Carcinoma (OPSCC) who will be treated with parotid-sparing head \& neck radiation. MRI Sialograms will be obtained to identify salivary ductal structures and stem cells to be spared during treatment.
Other: Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography
Head \& neck radiation with parotid sparing. Parotid sparing will be facilitated by avoidance of salivary ductal structures and stem cells, as identified by the pre-treatment MRI sialogram, in the radiation treatment plan.
Xerostomia
Patient reported xerostomia (dry mouth) after IMRT with salivary ductal sparing
Time frame: One year after completion of IMRT on last enrolled patient
Salivary Ductal Visibility
Correlation between mean dose to individual salivary gland ducts and post-treatment visibility scores
Time frame: One year after completion of IMRT on last enrolled patient
Salivary Gland Volume
Correlation between mean dose to individual salivary gland ducts and post-treatment salivary gland volume
Time frame: One year after completion of IMRT on last enrolled patient
Salivary Secretion Rate
Correlation between mean dose to individual salivary gland ducts and post-treatment saliva secretion rate
Time frame: One year after completion of IMRT on last enrolled patient
Salivary Secretion Recovery
Comparison of salivary secretion recovery rate after IMRT with salivary ductal sparing compared to current literature, particularly when irradiated glands exceed conventional dose constraints
Time frame: One year after completion of IMRT on last enrolled patient
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center