Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia
Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer
UNC Lineberger Comprehensive Cancer Center
98 participants
Jan 28, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- To participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained for the subject to be considered eligible for ongoing trial participation.
- Provide written informed consent to participate in the study and HIPAA authorization for release of personal health information.
- Able to comply with study procedures based on the judgment of the clinical investigator.
- Male or female, aged ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group performance status 0-2 at the time of consent.
- Women of reproductive potential must use highly effective contraception.
- T0-4, N0-3, M0 stage cancer of the oropharynx (American Joint Committee on Cancer Staging System 8th edition) planned for definitive radiotherapy +/- chemotherapy.
- No contraindications for magnetic resonance imaging (MRI).
Exclusion Criteria7
- An individual who meets any of the following criteria will be excluded from participation
- In this study:
- Patients with Sjogren's disease or baseline xerostomia.
- Patients with lesions involving the salivary glands on diagnostic imaging
- Patients with an allergy to lemon juice
- Prior lifetime history of radiation therapy to the head and neck
- Current pregnancy or lactation.
Interventions
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
Radiation therapy will be administered based on treatment planning that aims to minimize the dose to the parotid ducts.
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.
Locations(1)
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NCT07278557