Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

UNC Lineberger Comprehensive Cancer Center

Status: Withdrawn

Conditions: Xerostomia; Oropharynx Cancer; Head and Neck Cancer

Treatments: Radiation: standard radiotherapy; Radiation: experimental radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06276946

LCCC2244

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Mean Parotid

Active Comparator group

Description:

Standard radiotherapy planning aims to restrict the mean parotid radiation dose to less than or equal to 14 Gy.

Treatment:

Radiation: standard radiotherapy

Parotid Duct

Experimental group

Description:

Magnetic resonance images will be used to localize the parotid ducts and limit the radiation dose to these structures to less than or equal to 14 Gy.

Treatment:

Radiation: experimental radiotherapy