Status:
COMPLETED
Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Head and Neck Cancer
Oropharynx Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The proposed study is an attempt to improve patient xerostomia (dry mouth) after definitive radiation therapy treatment for head and neck cancer. Xerostomia is a frequently experienced symptom for tho...
Eligibility Criteria
Inclusion
- At least 18 years of age
- T0-4, N0-3, M0 disease of the oropharynx
- Will be treated with intensity modulated radiation therapy (IMRT) and with definitive intent (either definitive or postoperative radiotherapy)
- No contraindications to receiving an magnetic resonance imaging (MRI) such as: implanted electrical devices, pregnancy, and/or significant quantities of metal in the head/neck
- Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to treatment; at a minimum, chest x-ray is required (computerized tomography (CT) imaging of the chest or positron emission tomography (PET) /CT is acceptable)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Able to comply with the treatment plan and follow-up schedule
- Provides study-specific informed consent prior to study entry
Exclusion
- Sjogren's syndrome or baseline xerostomia (CTCAE \> 0 for question regarding dry mouth)
- Lesions grossly involving the salivary glands
- Allergy to lemon juice
- Prior history of radiation therapy to the head and neck
- Pre-treatment scan deemed not usable
Key Trial Info
Start Date :
March 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03418792
Start Date
March 8 2018
End Date
May 2 2023
Last Update
May 31 2023
Active Locations (1)
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1
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States, 27599