Nasal Inhalation of Isopropyl Alcohol for the Treatment of Nausea in Patients With Cancer
Inhalation Approaches to Nausea: A Randomized Controlled Trial
2 other identifiers
interventional
112
1 country
1
Brief Summary
The goal of this research study is to understand the effect of inhalation approaches in reducing nausea in cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2019
CompletedFirst Posted
Study publicly available on registry
November 29, 2019
CompletedStudy Start
First participant enrolled
November 5, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2028
Study Completion
Last participant's last visit for all outcomes
December 30, 2028
April 23, 2026
April 1, 2026
2.2 years
November 19, 2019
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Arm I (isopropyl alcohol)
EXPERIMENTALPatients receive isopropyl alcohol via nasal inhalation.
Arm II (placebo)
PLACEBO COMPARATORPatients receive placebo via nasal inhalation.
Interventions
Given via nasal inhalation
Given via nasal inhalation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yvonne J Heung
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2019
First Posted
November 29, 2019
Study Start (Estimated)
November 5, 2026
Primary Completion (Estimated)
December 30, 2028
Study Completion (Estimated)
December 30, 2028
Last Updated
April 23, 2026
Record last verified: 2026-04