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

RecruitingPhase 2Ages 18 Years - anyAllUNC Lineberger Comprehensive Cancer Center
NCT07278557 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • MRI sialography
  • Parotid Duct Sparing Radiation Therapy Planning
  • Parotid Sparing Radiation Therapy Planning
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Where

1 site
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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