Clinical trial NCT03418792: Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx
Official title: Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Oropharynx Cancer
Xerostomia Due to Radiotherapy
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 those receiving radiation therapies to the head and neck that persists after treatment, potentially indefinitely. It has been shown that stem/progenitor cells preferentially reside in large ducts of salivary glands and that these cells have the ability to repair radiation induced salivary damage. Current practice does not specifically attempt to spare these regions and considers the entire salivary gland to have equal importance and function. This study will involve the acquisition of pre-treatment MRI sialogram images which enable visualization of salivary ducts (using saliva itself as a contrast agent) that can then be avoided during radiation treatment planning. Saliva samples will also be collected at this time to quantify baseline saliva secretion and saliva characteristics. The primary objective will be to obtain patient reported outcomes (PRO) measure of xerostomia related symptoms for comparison with a historical cohort. Xerostomia symptom information will be obtained by use of a patient reported quality of life survey administered prior to treatment and at 6, 12, 18, and 24 months after treatment. The secondary objectives will be to quantitatively assess post-treatment changes in saliva secretion, salivary gland volume, and ductal visibility using MRI sialograms. The target sample size for this study is 40 patients. The investigator hypothesizes that reducing the dose to these stem cell containing salivary ducts will facilitate improvements in patient reported symptoms as well as improved recovery of salivary secretion, salivary gland volume, and intra-glandular ductal visibility using MRI sialograms.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Xerostomia
timeFrame: One year after completion of IMRT on last enrolled patient
Secondary outcomes:
measure: Salivary Ductal Visibility
timeFrame: One year after completion of IMRT on last enrolled patient
measure: Salivary Gland Volume
timeFrame: One year after completion of IMRT on last enrolled patient
measure: Salivary Secretion Rate
timeFrame: One year after completion of IMRT on last enrolled patient
measure: Salivary Secretion Recovery
timeFrame: One year after completion of IMRT on last enrolled patient
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Department of Radiation Oncology
state: North Carolina
Study officials:
affiliation: University of North Carolina at Chapel Hill, Department of Radiation Oncology
name: David V. Fried, PhD
role: PRINCIPAL_INVESTIGATOR
References: