Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer

NCT ID: NCT02338102

Last Updated: 2015-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Nasal Obstruction Rhinitis, Vasomotor Epistaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Saline mixture

Intervention Type OTHER

premeasured salt packets mixed with distilled water

Control Group

Subjects randomized to this arm receive no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Saline mixture

premeasured salt packets mixed with distilled water

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lisa Shnayder

OTHER

Sponsor Role lead

Responsible Party

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Lisa Shnayder

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yelizaveta Shnayder, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00000087

Identifier Type: -

Identifier Source: org_study_id

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