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NCT06276946 | NOT YET RECRUITING | Oropharynx Cancer

Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia
Sponsor:

UNC Lineberger Comprehensive Cancer Center

Brief 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.

Condition or disease

Oropharynx Cancer

Head and Neck Cancer

Xerostomia

Intervention/treatment

standard radiotherapy

experimental radiotherapy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 98 participants
Masking : DOUBLE
Primary Purpose : PREVENTION
Official Title : Randomized Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer
Actual Study Start Date : 2025-05-08
Estimated Primary Completion Date : 2028-07
Estimated Study Completion Date : 2029-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    • Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

    Location Details

    NCT06276946

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United States, North Carolina

    University of North Carolina at Chapel Hill, Department of Radiation Oncology

    Chapel Hill, North Carolina, United States, 27599