NCT07278557 Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia
| NCT ID | NCT07278557 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2030-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 98 participants in total. It began in 2026-01-28 with a primary completion date of 2030-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
David Fried, PhD
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07278557 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07278557 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07278557 currently recruiting?
Yes, NCT07278557 is actively recruiting participants. Contact the research team at tjking@med.unc.edu for enrollment information.
Where is the NCT07278557 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07278557 clinical trial?
NCT07278557 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is David Fried, PhD at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 98 participants.
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