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Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer

Primary Purpose

Nasal Obstruction, Rhinitis, Vasomotor, Epistaxis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saline mixture
Sponsored by
Lisa Shnayder
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

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.

Subjects randomized to this arm receive no intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2015
Last Updated
November 2, 2015
Sponsor
Lisa Shnayder
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1. Study Identification

Unique Protocol Identification Number
NCT02338102
Brief Title
Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer
Official Title
Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lisa Shnayder

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction, Rhinitis, Vasomotor, Epistaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subjects randomized to this arm receive no intervention.
Intervention Type
Other
Intervention Name(s)
Saline mixture
Intervention Description
premeasured salt packets mixed with distilled water
Primary Outcome Measure Information:
Title
Change in quality of life, measured using Sino-Nasal Outcome Test (SNOT-20) summary scores
Description
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.
Time Frame
Change from Baseline to Month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yelizaveta Shnayder, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer

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