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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04181463
Collaborator
National Cancer Institute (NCI) (NIH)
112
Enrollment
1
Location
2
Arms
27
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Isopropyl Alcohol
  • Other: Placebo
  • Other: Questionnaire Administration
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Inhalation Approaches to Nausea: A Randomized Controlled Trial
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (isopropyl alcohol)

Patients receive isopropyl alcohol via nasal inhalation.

Drug: Isopropyl Alcohol
Given via nasal inhalation
Other Names:
  • Isopropanol
  • Isopropanolol

    • Other: Questionnaire Administration
    Ancillary studies
    Placebo Comparator: Arm II (placebo)

    Patients receive placebo via nasal inhalation.

    Other: Placebo
    Given via nasal inhalation
    Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Change in nausea [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Yvonne J Heung, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04181463
    Other Study ID Numbers:
    • 2019-0472
    • NCI-2019-07377
    • 2019-0472
    First Posted:
    Nov 29, 2019
    Last Update Posted:
    May 17, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of May 17, 2022