- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04181463
Nasal Inhalation of Isopropyl Alcohol for the Treatment of Nausea in Patients With Cancer
Inhalation Approaches to Nausea: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Michael J Tang, MD
- Phone Number: (832) 468-8895
- Email: MJTang@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
Principal Investigator:
- Michael J. Tang
-
Contact:
- Michael J. Tang, MD
- Phone Number: 832-468-8895
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (isopropyl alcohol)
Patients receive isopropyl alcohol via nasal inhalation.
|
Ancillary studies
Given via nasal inhalation
Other Names:
|
|
Placebo Comparator: Arm II (placebo)
Patients receive placebo via nasal inhalation.
|
Ancillary studies
Given via nasal inhalation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in nausea
Time Frame: 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.
|
Baseline up to 5 minutes post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yvonne J Heung, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0472 (Other Identifier: M D Anderson Cancer Center)
- NCI-2019-07377 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malignant Neoplasm
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedMetastatic Malignant Neoplasm | Unresectable Malignant Neoplasm | Advanced Malignant NeoplasmUnited States
-
Mayo ClinicRecruitingMalignant Abdominal Neoplasm | Malignant Pelvic Neoplasm | Childhood Malignant Solid Neoplasm | Childhood Malignant Thoracic Neoplasm | Malignant Neck Neoplasm | Metastatic Childhood Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Liver | Unresectable Solid NeoplasmUnited States, Canada
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Rare Malignant Solid Neoplasm | Rare Malignant Solid Neoplasm | Refractory Rare Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterTerminatedLocally Advanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMalignant Neoplasm | Metastatic Malignant Neoplasm | Advanced Malignant Neoplasm | Recurrent Malignant Neoplasm | Locally Advanced Malignant NeoplasmUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Malignant Neoplasm | Advanced Malignant Neoplasm | Recurrent Malignant Neoplasm | Refractory Malignant Neoplasm | Locally Advanced Malignant NeoplasmUnited States
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedAdvanced Malignant Neoplasm | Locally Advanced Malignant NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedMetastatic Malignant Neoplasm | Advanced Malignant Neoplasm | Recurrent Malignant Neoplasm | Refractory Malignant NeoplasmUnited States
Clinical Trials on Questionnaire Administration
-
Fondazione Don Carlo Gnocchi OnlusCompleted
-
Centre Oscar LambretCentre Hospitalier Universitaire de BesanconTerminated
-
Hospital Clínico Universitario de ValladolidRed Centinela Sanitaria de Castilla y León (RCSCYL); Centro Nacional de Gripe... and other collaboratorsRecruitingMigraine | Headache Disorders | Viral Infection | Influenza -Like Illness | Head PainSpain
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingBreast Ductal Carcinoma In Situ | Invasive Breast Carcinoma | COVID-19 Infection | Hereditary Breast CarcinomaUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingAdvanced Malignant Solid Neoplasm | Hematopoietic and Lymphoid System NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Recurrent Lymphoma | Recurrent Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Recurrent Plasma Cell Myeloma | Caregiver | Recurrent LeukemiaUnited States
-
Gulseren Demir KarakilicCompletedMusculoskeletal Diseases | Chronic PainTurkey (Türkiye)
-
I.M. Sechenov First Moscow State Medical UniversityAgency of Social Information St. PetersburgActive, not recruiting
-
I.M. Sechenov First Moscow State Medical UniversityActive, not recruitingShoulder ArthropathyRussian Federation
-
Karolinska University HospitalSahlgrenska University Hospital, Sweden; University Hospital, Linkoeping; Skane...Active, not recruitingQuality of Life | Vulvar CancerSweden