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NCT Number: NCT04181463

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location contact

Michael J. Tang

PRINCIPAL_INVESTIGATOR

Michael J. Tang, MD

CONTACT

832-468-8895

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Isopropyl Alcohol

Drug

Given via nasal inhalation

Other names: Isopropanol, Isopropanolol

Placebo

Other

Given via nasal inhalation

Other names: placebo therapy, PLCB, sham therapy

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Change in nausea

    Time frame: Baseline up to 5 minutes post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael J Tang, MD

CONTACT

[email protected]

(832) 468-8895

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Inhalation Approaches to Nausea: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 29, 2019
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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