Malignant Neoplasm
Conditions
Brief summary
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
Given via nasal inhalation
OTHERPlacebo
Given via nasal inhalation
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactYvonne J Heung
Outcome results
None listed