CClinicalTrials.gg
CompletedNCT03418792Updated May 31, 2023

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

An interventional study of Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography in Head and Neck Cancer, Oropharynx Cancer and Xerostomia Due to Radiotherapy, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Head and Neck Cancer
  • Oropharynx Cancer
  • Xerostomia Due to Radiotherapy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Parotid-Sparing Head & Neck Radiation

    Patients with Oropharyngeal Squamous Cell Carcinoma (OPSCC) who will be treated with parotid-sparing head \& neck radiation. MRI Sialograms will be obtained to identify salivary ductal structures and stem cells to be spared during treatment.

    Other: Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography

Interventions

  • OtherParotid-Sparing Head & Neck Radiation Guided by MRI Sialography

    Head \& neck radiation with parotid sparing. Parotid sparing will be facilitated by avoidance of salivary ductal structures and stem cells, as identified by the pre-treatment MRI sialogram, in the radiation treatment plan.

05

What researchers measure

Primary outcomes

  1. Xerostomia

    Patient reported xerostomia (dry mouth) after IMRT with salivary ductal sparing

    Time frame: One year after completion of IMRT on last enrolled patient

Secondary outcomes

  1. Salivary Ductal Visibility

    Correlation between mean dose to individual salivary gland ducts and post-treatment visibility scores

    Time frame: One year after completion of IMRT on last enrolled patient

  2. Salivary Gland Volume

    Correlation between mean dose to individual salivary gland ducts and post-treatment salivary gland volume

    Time frame: One year after completion of IMRT on last enrolled patient

  3. Salivary Secretion Rate

    Correlation between mean dose to individual salivary gland ducts and post-treatment saliva secretion rate

    Time frame: One year after completion of IMRT on last enrolled patient

  4. Salivary Secretion Recovery

    Comparison of salivary secretion recovery rate after IMRT with salivary ductal sparing compared to current literature, particularly when irradiated glands exceed conventional dose constraints

    Time frame: One year after completion of IMRT on last enrolled patient

06

Study locations

1 site
  • University of North Carolina at Chapel Hill, Department of Radiation Oncology
    Chapel Hill, North Carolina 27599, United States
07

Registry details

Key details

Study ID
NCT03418792
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Responsible party
Sponsor
First posted
Feb 1, 2018
Start date
Mar 8, 2018
Primary completion
Apr 22, 2022
Completion
May 2, 2023
Last update
May 31, 2023

Study contacts

David V. Fried, PhD
principal investigator · University of North Carolina at Chapel Hill, Department of Radiation Oncology

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion