Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer
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|ClinicalTrials.gov Identifier: NCT02338102|
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : November 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Nasal Obstruction Rhinitis, Vasomotor Epistaxis||Other: Saline mixture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Yelizaveta Shnayder, MD||University of Kansas Medical Center|