Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to help reduce dry mouth, also known as xerostomia, in patients with oropharynx cancer who are receiving radiation therapy. Dry mouth is a common side effect of radiation treatment for head and neck cancers, and it can be uncomfortable and long-lasting. The study is testing whether using MRI (a type of imaging) to carefully plan radiation therapy can better protect the parotid ducts, which are important for saliva production. By doing this, the researchers hope to improve patients' quality of life after treatment by reducing dry mouth symptoms.

To participate in the trial, individuals must be at least 18 years old and have a specific type of oropharynx cancer that requires radiation therapy. Participants will need to provide informed consent and be willing to follow the study's procedures. However, those with certain conditions, like Sjogren's syndrome (which causes dry mouth) or prior radiation to the head and neck, won't be eligible. If you join the study, you can expect to share your experiences with dry mouth, and the research team will monitor your saliva production and other related factors during and after your treatment. This trial aims to find better ways to manage the side effects of cancer treatment and improve patients' overall comfort.

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Eligibility criteria

• • In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained up for the subject to be considered eligible for treatment.
• • Inclusion Criteria
• • 1. Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
• • 2. Subjects is willing and able to comply with study procedures based on the judgment of the investigator.
• • 3. Age ≥ 18 years at the time of consent.
• • 4. T0-4, N0-3, M0 disease American Joint Committee on Cancer (AJCC 7th or 8th edition) of the oropharynx (this includes patients with head and neck cancer of unknown primary origin, often categorized as T0 disease, who will be treated with radiotherapy to the oropharynx) planned for definitive radiotherapy +/- chemotherapy
• • 5 No contraindications to receiving MRI such as implanted electrical devices, pregnancy, and significant quantities of metal in the head/neck
• • Exclusion Criteria
• • 1. Patients with Sjogren's syndrome or baseline xerostomia (CTCAE \> 0 for the question regarding dry mouth)
• • 2. Patients with lesions grossly involving the salivary glands
• • 3. Patients with an allergy to lemon juice
• • 4. Prior history of radiation therapy to the head and neck