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Trial Title:
Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia
NCT ID:
NCT06276946
Condition:
Oropharynx Cancer
Head and Neck Cancer
Xerostomia
Conditions: Official terms:
Oropharyngeal Neoplasms
Xerostomia
Conditions: Keywords:
radiotherapy
magnetic resonance imaging
parotis
parotid duct
radiotherapy dosimetry
radiotherapy planning
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Radiation
Intervention name:
standard radiotherapy
Description:
radiotherapy planning goal is to restrict the mean parotid dose is equal to or less than
14Gy.
Arm group label:
Mean Parotid
Intervention type:
Radiation
Intervention name:
experimental radiotherapy
Description:
radiotherapy planning goal is to restrict the parotid duct dose is equal to or less than
14Gy
Arm group label:
Parotid Duct
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Start date:
December 8, 2024
Completion date:
January 2029
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06276946
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
