Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer
UNC Lineberger Comprehensive Cancer Center
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.
Description
Radiation-induced dry mouth (xerostomia) is the most commonly reported long-term side effect in patients receiving radiation therapy (RT) for head and neck cancer. It occurs when saliva production decreases and the saliva becomes thicker. Patients with xerostomia often have trouble chewing, swallowing, and speaking, and are more likely to develop tooth decay. These problems can significantly lower a patient's quality of life-and the impact tends to get worse over time. The most common way to reduce radiation-related dry mouth is by limiting the average radiation dose to the parotid glands (wh…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceMRI sialography
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
- OtherParotid Duct Sparing Radiation Therapy Planning
Radiation therapy will be administered based on treatment planning that aims to minimize the dose to the parotid ducts.
- OtherParotid Sparing Radiation Therapy Planning
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.
Location
- University of North Carolina at Chapel Hill, Department of Radiation OncologyChapel Hill, North Carolina