# A Phase II Randomized Assessment of Sparing Parotid Ducts via MRI Sialography for Reduced Patient Reported Xerostomia

> **NIH NIH UG3** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2024 · $357,398

## Abstract

Abstract: Dry mouth (xerostomia) is one of the most common and severe toxicities that patients
experience after radiotherapy (RT) for head and neck cancer. Xerostomia results from RT-induced
damage to the salivary glands and is associated with difficulties in chewing, swallowing, speaking,
as well as increases in occurrence of dental carries, all decreasing the patient’s quality of life.
Existing methods to prevent xerostomia are often not very helpful to the patient, difficult to
implement, and can cause additional toxicities. In an attempt to reduce the morbidity of treatment,
dose-reduced chemoradiotherapy regimens where patients with favorable-risk HPV-associated
tumors are treated with 60Gy (Chera 2019) compared to the conventional 70Gy have been
introduced. While dose reduction has led to an overall improved symptom profile, xerostomia
remained the most severe patient-reported toxicity. Thus, additional methods to minimize RT-
induced xerostomia are needed. Data suggest that salivary stem/progenitor cells, which
preferentially reside within the large salivary ducts, have the potential to regenerate salivary
glands post-injury. Our hypothesis is that dose sparing of the stem cells within the parotid ducts
will improve patient outcomes compared to conventional parotid sparing (i.e., attempting to limit
the mean dose of the contralateral parotid gland to less than 26Gy). In order to evaluate the utility
of parotid ductal sparing formally, we will conduct a randomized double-blind trial. Patients with
oropharyngeal squamous cell carcinomas will be randomized to receive parotid ductal sparing
(using MRI-sialography to identify the ducts) or conventional parotid sparing RT.

## Key facts

- **NIH application ID:** 10780160
- **Project number:** 1UG3DE033389-01
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** DAVID V FRIED
- **Activity code:** UG3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $357,398
- **Award type:** 1
- **Project period:** 2024-04-16 → 2025-07-15

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10780160

## Citation

> US National Institutes of Health, RePORTER application 10780160, A Phase II Randomized Assessment of Sparing Parotid Ducts via MRI Sialography for Reduced Patient Reported Xerostomia (1UG3DE033389-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10780160. Licensed CC0.

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