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

M.D. Anderson Cancer Center

Status and phase: Not yet enrolling; Phase 2

Conditions: Malignant Neoplasm

Treatments: Other: Questionnaire Administration; Other: Placebo; Drug: Isopropyl Alcohol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04181463

2019-0472 (Other Identifier)

NCI-2019-07377 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups, including a placebo group

Arm I (isopropyl alcohol)

Experimental group

Description:

Patients receive isopropyl alcohol via nasal inhalation.

Treatment:

Drug: Isopropyl Alcohol

Other: Questionnaire Administration

Arm II (placebo)

Placebo Comparator group

Description:

Patients receive placebo via nasal inhalation.

Treatment:

Other: Placebo

Other: Questionnaire Administration