Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer

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

Completed

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Key information

Conditions

Nasal Obstruction Airway Obstruction Epistaxis Hemorrhage Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Rhinitis Rhinitis, Vasomotor Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline mixture

Other

premeasured salt packets mixed with distilled water

Primary outcomes

Change in quality of life, measured using Sino-Nasal Outcome Test (SNOT-20) summary scores

Time frame: Change from Baseline to Month 2

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.

Sponsors and collaborators

Lead sponsor

Lisa Shnayder

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jan 14, 2015
Registry last updated: Nov 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed