Clinical trial NCT06276946: Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia
Official title: Randomized Assessment of Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia Following Radiotherapy for Oropharynx Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oropharynx Cancer
Head and Neck Cancer
Xerostomia
Keywords: radiotherapy
magnetic resonance imaging
parotis
parotid duct
radiotherapy dosimetry
radiotherapy planning
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The difference in patient-reported xerostomia 6 months
timeFrame: 6 months after completion of radiotherapy
Secondary outcomes:
measure: Saliva mass
timeFrame: 6 months and 12 months after completion of radiotherapy
measure: Parotid duct dose constraint
timeFrame: 6 months after completion of radiotherapy
measure: The difference in patient-reported xerostomia 12 months
timeFrame: 12 months after completion of radiotherapy
measure: Xerostomia by NCI-CTCAE
timeFrame: 12 months after completion of radiotherapy
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: UNC Lineberger Comprehensive Cancer Center
name: Colette Shen, MD
role: PRINCIPAL_INVESTIGATOR
References: