Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer

NCT02338102 | Completed

• 1 other identifier: STUDY00000087
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasal Obstruction; Rhinitis, Vasomotor; Epistaxis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Subjects randomized to this arm receive no intervention.

Interventions

Saline mixture OTHER

premeasured salt packets mixed with distilled water

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients seen in the KUMC Ear, Nose and Throat clinic with oropharyngeal cancer that have undergone radiation therapy as the primary treatment

You may not qualify if:

• Patients that are at high risk for infection secondary to nasal irrigation
• Patients with autoimmune disease or immune deficiency

Sponsors & Collaborators

• Lisa Shnayder: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Nasal Obstruction; Rhinitis, Vasomotor; Epistaxis

Condition Hierarchy (Ancestors)

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

Study Officials

• Yelizaveta Shnayder, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 14, 2015
• Study Start: January 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 4, 2015

Record last verified: 2015-11

Locations

US (1)