Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

UNC Lineberger Comprehensive Cancer Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

Oropharynx Cancer Head and Neck Cancer Xerostomia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The difference in patient-reported xerostomia 6 months

The difference in patient-reported xerostomia will be assessed using the MD Anderson Symptom Inventory -Head \& Neck (MDASI-HN) questionnaire. MDASI multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Use the MDASI to assess the severity of symptoms Each question is scaled from 0 to 10. 0= not present and 10= as bad as you imagine.

Time frame: 6 months after completion of radiotherapy

Secondary Outcomes

Saliva mass

The mass of generated saliva post-radiation treatment will be measured.

Time frame: 6 months and 12 months after completion of radiotherapy

Parotid duct dose constraint

The efficacy of 14Gy parotid duct constraint for subjects undergoing parotid ductal sparing radiation therapy will be measured using patient-reported xerostomia scores.

Time frame: 6 months after completion of radiotherapy

The difference in patient-reported xerostomia 12 months

The difference in patient-reported xerostomia will be assessed using the MD Anderson Symptom Inventory -Head \& Neck (MDASI-HN) questionnaire. MDASI multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Each question is scaled from 0 to 10. 0= not present and 10= as bad as you imagine.

Time frame: 12 months after completion of radiotherapy

Xerostomia by NCI-CTCAE

xerostomia will be assessed using The National Cancer Institute Common Terminology Criteria for Adverse Events is a descriptive terminology (NCI-CTCAE) v5.0 that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.