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

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 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.

Conditions2

Locations1 site

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