Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02338102
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):
Lisa Shnayder, University of Kansas Medical Center

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

Condition or disease Intervention/treatment Phase
Nasal Obstruction Rhinitis, Vasomotor Epistaxis Other: Saline mixture Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer: A Pilot Study
Study Start Date : January 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
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
premeasured salt packets mixed with distilled water

No Intervention: Control Group
Subjects randomized to this arm receive no intervention.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338102


Locations
Layout table for location information
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Lisa Shnayder
Investigators
Layout table for investigator information
Principal Investigator: Yelizaveta Shnayder, MD University of Kansas Medical Center
Layout table for additonal information
Responsible Party: Lisa Shnayder, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02338102    
Other Study ID Numbers: STUDY00000087
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Oropharyngeal Neoplasms
Rhinitis
Epistaxis
Nasal Obstruction
Rhinitis, Vasomotor
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Hemorrhage
Pathologic Processes
Signs and Symptoms, Respiratory
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders