Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to learn whether nasal saline irrigation is beneficial to patients undergoing radiation therapy for oropharyngeal cancer.

Detailed Description
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In this study, subjects are randomized to one of two study arms. They are either randomized to receive nasal saline irrigation treatment (treatment group) or not to receive any nasal irrigation treatment (control group). Subjects randomized to the treatment group will be provided with saline packets to mix with water. All study subjects will be asked to complete questionnaires during the study. If a subject completes all study related activities, their total length of participation in the study will last about 2 months.

Official Title
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Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer: A Pilot Study

Conditions
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Epistaxis, Nasal Obstruction, Rhinitis, Vasomotor

Intervention / Treatment
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* Other: Saline mixture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients seen in the KUMC Ear, Nose and Throat clinic with oropharyngeal cancer that have undergone radiation therapy as the primary treatment Exclusion Criteria: Patients that are at high risk for infection secondary to nasal irrigation Patients with autoimmune disease or immune deficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Subjects in this group will perform twice daily nasal irrigations. Nasal irrigations will be performed by using premeasured salt packets mixed with distilled water in NeilMed irrigation bottles. The subject will be instructed to lean forward over the sink, place the bottle up to the nostril, and hold their breath while gently squeezing the bottle. One bottle is used to irrigate both nostrils, using half the solution on each side. | Other: Saline mixture<br>* premeasured salt packets mixed with distilled water<br>|
| No Intervention: Control Group<br>Subjects randomized to this arm receive no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life, measured using Sino-Nasal Outcome Test (SNOT-20) summary scores | Outcome measured using Sino-Nasal Outcome Test (SNOT-20) summary scores. Scores will be collected at the baseline visit and again on the Month 2 visit. Outcome represented as a change in mean summary scores between the two visits. Scores can range from 0-5 with 0 being the best and 5 being the worst. | Change from Baseline to Month 2 |