CompletedNot Applicable

Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx

United States40 participantsStarted 2018-03-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Xerostomia

Timeframe: One year after completion of IMRT on last enrolled patient

Trial details

NCT IDNCT03418792

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-22

View on ClinicalTrials.gov More Head and Neck Cancer trials