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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: UNC Lineberger Comprehensive Cancer Center • ClinicalTrials.gov ID: NCT07278557

Registry updated: 2026-10-13
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Description

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.

Interventions

  • MRI sialography (Device)
    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
  • Parotid Duct Sparing Radiation Therapy Planning (Other)
    Radiation therapy will be administered based on treatment planning that aims to minimize the dose to the parotid ducts.
  • Parotid Sparing Radiation Therapy Planning (Other)
    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.

Eligibility criteria

Inclusion Criteria: 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 Criteria: 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.

Conditions

Head and Neck Cancer

Locations

  • University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill, North Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record