Nasal Inhalation of Isopropyl Alcohol for the Treatment of Nausea in Patients With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Isopropyl Alcohol, Placebo, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Malignant Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Inhalation Approaches to Nausea: A Randomized Controlled Trial
Overview
The goal of this research study is to understand the effect of inhalation approaches in reducing nausea in cancer patients.
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.
Interventions
- Drug Isopropyl Alcohol
Given via nasal inhalation - Other Placebo
Given via nasal inhalation - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Change in nausea [Time frame: Baseline up to 5 minutes post-intervention]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT04181463 · 2019-0472 · NCI-2019-07377 · 2019-0472