Nasal Inhalation of Isopropyl Alcohol for the Treatment of Nausea in Patients With Cancer

Study Overview
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Brief Summary
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The goal of this research study is to understand the effect of inhalation approaches in reducing nausea in cancer patients.

Detailed Description
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In this study, inhalation of a study solution will be compared to inhalation of placebo, both in the form of preparation pads (a small square of material that contains the solution). Isopropyl alcohol may be a part of the preparation pads. A placebo is not a drug. It looks like the study solution but is not designed to treat any disease or illness. It is designed to be compared with the study solution to learn if the study solution has any real effect. Inhalation of the study solution may help to control your nausea. Future patients may benefit from what is learned. There may be no benefits for you in this study. Your participation is completely voluntary. Before choosing to take part in this study, you should discuss with the study team any concerns you may have, including side effects, potential expenses, and time commitment.

Official Title
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Inhalation Approaches to Nausea: A Randomized Controlled Trial

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Drug: Isopropyl Alcohol
* Other: Placebo
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rate current severity of acute/chronic nausea >= 4 on NRS (Numeric Rating Scale) Diagnosis of cancer Able to read/write in English Referred to supportive care service as an inpatient or outpatient Rate anxiety as =< 4 on ESAS-FS (Edmonton Symptom Assessment Scale-Financial Distress and Spiritual Pain) Participants must agree to inhale isopropyl alcohol Exclusion Criteria: Received anti-emetics in the last 30 minutes Received medical procedures (e.g. blood draws) which required exposure of isopropyl alcohol in the last 30 minutes Inability to inhale through nares (including recent upper respiratory infection) Known allergy to isopropyl alcohol Delirium (i.e., score >= 7 on the Memorial Delirium Assessment Scale [MDAS]) Have never been on anti-emetics during the course of the treatment here (anti-emetic naive)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (isopropyl alcohol)<br>Patients receive isopropyl alcohol via nasal inhalation. | Drug: Isopropyl Alcohol<br>* Given via nasal inhalation<br>* Other names: Isopropanolol;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Placebo Comparator: Arm II (placebo)<br>Patients receive placebo via nasal inhalation. | Other: Placebo<br>* Given via nasal inhalation<br>* Other names: sham therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nausea | The mean change in nausea level will be compared between the two arms by two sample t-test. In case there's any violation in the underlying assumptions (e.g. normality, equality of variance, etc.) proper transformation (e.g. logarithm, square root, etc.) or non-parametric methods (Wilcoxon rank sum test) will be applied. | Baseline up to 5 minutes post-intervention |