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Not Yet Recruiting PHASE2 INTERVENTIONAL NCT07278557

Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Radiation-induced xerostomia (dry mouth) is one of the most common and severe side effects for patients receiving radiation therapy for head and neck cancer. New approaches are needed to reduce this side effect and improve patients' quality of life after treatment. This is a Phase II, single-center, double-masked, parallel-arm, randomized controlled trial. It compares MRI-guided parotid ductal sparing to the standard approach of mean parotid gland sparing, focusing on patient-reported dry mouth outcomes in individuals receiving definitive radiotherapy for oropharyngeal cancer.

Detailed Description

Radiation-induced dry mouth (xerostomia) is the most commonly reported long-term side effect in patients receiving radiation therapy (RT) for head and neck cancer. It occurs when saliva production decreases and the saliva becomes thicker. Patients with xerostomia often have trouble chewing, swallowing, and speaking, and are more likely to develop tooth decay. These problems can significantly lower a patient's quality of life-and the impact tends to get worse over time. The most common way to reduce radiation-related dry mouth is by limiting the average radiation dose to the parotid glands (which produce saliva). However, this is often not possible because of the patient's anatomy, and many patients still report moderate to severe symptoms long after treatment. To reduce side effects, some studies have tested giving a lower radiation dose (60Gy instead of the usual 70Gy) in patients with low-risk, HPV-associated tumors. While this has helped improve overall symptoms, xerostomia still remains the most severe and persistent problem reported by patients. New strategies are needed to better protect patients from radiation-related dry mouth and help maintain their quality of life after treatment. Recent research shows that the parotid gland does not respond evenly to radiation; certain areas, especially large salivary ducts where stem/progenitor cells live, may be key for recovery after damage. If these ducts can be located during treatment planning, the radiation dose to them could be reduced. A pilot study showed that using MRI sialography to identify the parotid ducts and plan radiation therapy around them is both possible and promising. Patients who received this type of duct-sparing RT had fewer moderate-to-severe dry mouth symptoms compared to patients treated with standard RT (46% vs. 71% at 6 months, and 36% vs. 50% at 12 months post-treatment). A larger, randomized study is still needed to confirm whether reducing radiation dose to the parotid ducts can meaningfully lower the risk of xerostomia and improve recovery after radiation treatment.

Interventions

Name: MRI sialography
Type: DEVICE
Description: Prior to radiation therapy treatment planning, all participants will undergo magnetic resonance imaging (MRI) sialography in order to visualize patients' parotid ducts. This will enable these organs-at-risk to be spared during radiation treatment planning
Name: Parotid Duct Sparing Radiation Therapy Planning
Type: OTHER
Description: Radiation therapy will be administered based on treatment planning that aims to minimize the dose to the parotid ducts.
Name: Parotid Sparing Radiation Therapy Planning
Type: OTHER
Description: Radiation therapy will be administered based on treatment planning that uses the entire parotid gland volume as the organ-at-risk, in accordance with standard clinical practice. The parotid ducts will not be considered separately.

Primary Outcomes

Measure: The rate of xerostomia score based on the University of Michigan Xerostomia -6 months Questionnaire - 6 months
TimeFrame: 6 months
Description: The rate of xerostomia score based on the University of Michigan Xerostomia Questionnaire (UMXQ) will be determined. UMXQ is an eight-item patient-reported instrument designed to assess the severity of xerostomia (dry mouth), gauging symptoms both during and outside of eating or chewing. The score ranges from 0 to 100, with higher scores indicating worse xerostomia. Participants treated with parotid ductal sparing radiotherapy will be compared.

Trial Information

NCT ID

NCT07278557

Status

Not Yet Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last Updated

December 15, 2025