WithdrawnNot Applicable

Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

Stopped: Operational reason

United States0Started 2025-08-08

Plain-language summary

Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment. This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
✓. Subjects is willing and able to comply with study procedures based on the judgment of the investigator.
✓. Age ≥ 18 years at the time of consent.
✓. 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

Exclusion criteria

✕. Patients with Sjogren's syndrome or baseline xerostomia (CTCAE \> 0 for the question regarding dry mouth)
✕. Patients with lesions grossly involving the salivary glands
✕. Patients with an allergy to lemon juice
✕. Prior history of radiation therapy to the head and neck

What they're measuring

The difference in patient-reported xerostomia 6 months

Timeframe: 6 months after completion of radiotherapy

Trial details

NCT IDNCT06276946

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07

View on ClinicalTrials.gov More Oropharynx Cancer trials