Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for individuals with dry mouth due to radiation treatment for cancers in the throat or head and neck area. Participants must have a diagnosis of oropharyngeal cancer and be scheduled to receive radiotherapy.Inclusion Criteria
Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information
I am 18 years old or older.
I am willing and able to follow the study's requirements.
+2 more
Exclusion Criteria
Patients with an allergy to lemon juice
I have had radiation therapy to my head or neck before.
I have Sjogren's syndrome or I often have a very dry mouth.
+1 more
Participant Groups
The study compares standard radiotherapy with an experimental approach that uses MRI to try sparing parts of the salivary glands during treatment, aiming to reduce dry mouth symptoms after therapy.
2Treatment groups
Experimental Treatment
Active Control
Group I: Parotid DuctExperimental Treatment1 Intervention
Magnetic resonance images will be used to localize the parotid ducts and limit the radiation dose to these structures to less than or equal to 14 Gy.
Group II: Mean ParotidActive Control1 Intervention
Standard radiotherapy planning aims to restrict the mean parotid radiation dose to less than or equal to 14 Gy.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of North Carolina at Chapel Hill, Department of Radiation OncologyChapel Hill, NC
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Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor