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

NCT ID: NCT04181463

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2025-12-30

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.

Conditions

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Malignant Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (isopropyl alcohol)

Patients receive isopropyl alcohol via nasal inhalation.

Group Type EXPERIMENTAL

Isopropyl Alcohol

Intervention Type DRUG

Given via nasal inhalation

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (placebo)

Patients receive placebo via nasal inhalation.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Given via nasal inhalation

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Isopropyl Alcohol

Given via nasal inhalation

Intervention Type DRUG

Placebo

Given via nasal inhalation

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Isopropanol Isopropanolol placebo therapy PLCB sham therapy

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yvonne J Heung

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Yvonne J Heung

Role: CONTACT

713-792-6085

Facility Contacts

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Yvonne J. Heung

Role: primary

713-792-6085

Related Links

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http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

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NCI-2019-07377

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-0472

Identifier Type: OTHER

Identifier Source: secondary_id

2019-0472

Identifier Type: -

Identifier Source: org_study_id

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