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Radiation

Parotid Duct for Oropharyngeal Cancer

N/A

Waitlist Available

Led By Colette Shen, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

T0-4, N0-3, M0 disease American Joint Committee on Cancer (AJCC 7th or 8th edition) of the oropharynx planned for definitive radiotherapy +/- chemotherapy

Age ≥ 18 years at the time of consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after completion of radiotherapy

Awards & highlights

Study Summary

This trial aims to reduce dry mouth in patients with oropharynx cancer undergoing radiation therapy. The study will use MRI to guide the definition of salivary gland ducts in order to spare them

Who is the study for?

This trial is for individuals with dry mouth due to radiation treatment for cancers in the throat or head and neck area. Participants must have a diagnosis of oropharyngeal cancer and be scheduled to receive radiotherapy.Check my eligibility

What is being tested?

The study compares standard radiotherapy with an experimental approach that uses MRI to try sparing parts of the salivary glands during treatment, aiming to reduce dry mouth symptoms after therapy.See study design

What are the potential side effects?

Standard radiotherapy can cause persistent dry mouth, changes in saliva secretion, pH level alterations, and potential discomfort. The new method's side effects are being studied but may include similar issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My throat cancer is at a stage where it can be treated with radiation, with or without chemotherapy.

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I am 18 years old or older.

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I can safely undergo an MRI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after completion of radiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after completion of radiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after completion of radiotherapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The difference in patient-reported xerostomia 6 months

Secondary outcome measures

Parotid duct dose constraint

Saliva mass

The difference in patient-reported xerostomia 12 months

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Parotid DuctExperimental Treatment1 Intervention

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.

Group II: Mean ParotidActive Control1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,142 Total Patients Enrolled

Colette Shen, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

1 Previous Clinical Trials

115 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ongoing efforts to actively enlist participants for this medical study?

"According to clinicaltrials.gov, patient enrollment is not active for this particular investigation. The trial was listed on 3/8/2024 and last updated on 2/23/2024. Although recruitment is paused, there are currently 408 other trials seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

2024. "Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06276946.

All > Radiotherapy