Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer

Nasal Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338102
• Other study ID #: STUDY00000087
• Status: Completed
• Phase: N/A
• First received: January 9, 2015
• Last updated: November 2, 2015
• Start date: January 2013
• Est. completion date: May 2015

Study information

• Verified date: November 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epistaxis
• Nasal Obstruction
• Oropharyngeal Neoplasms
• Rhinitis, Vasomotor

Intervention

Other:
• Saline mixture
premeasured salt packets mixed with distilled water

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Lisa Shnayder

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No