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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07377 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0472 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The goal of this research study is to understand the effect of inhalation approaches in reducing nausea in cancer patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (isopropyl alcohol) | Experimental | Patients receive isopropyl alcohol via nasal inhalation. |
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| Arm II (placebo) | Placebo Comparator | Patients receive placebo via nasal inhalation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isopropyl Alcohol | Drug | Given via nasal inhalation |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in nausea | 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. | Baseline up to 5 minutes post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael J Tang, MD | Contact | (832) 468-8895 | MJTang@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Yvonne J Heung | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019840 | 2-Propanol |
| ID | Term |
|---|---|
| D020005 | Propanols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Other | Given via nasal inhalation |
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| Questionnaire Administration | Other | Ancillary studies |
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