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

Malignant Neoplasm Clinical Trial

Official title:

Inhalation Approaches to Nausea: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04181463
• Other study ID #: 2019-0472
• Secondary ID: NCI-2019-0737720
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 5, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: M.D. Anderson Cancer Center
• Contact: Yvonne J Heung
• Phone: 713-792-6085
• Email: yjheung[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Drug:
• Isopropyl Alcohol
Given via nasal inhalation

Other:
• Placebo
Given via nasal inhalation
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center