Malignant NeoplasmPhase 2NCT04181463
Nasal Inhalation of Isopropyl Alcohol for the Treatment of Nausea in Patients With Cancer
A Phase 2 study testing Isopropyl Alcohol and Questionnaire Administration in people with Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to understand the effect of inhalation approaches in reducing nausea in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Isopropyl Alcohol and Questionnaire Administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2026to 30 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
M D Anderson Cancer Center
Houston, Texas, 77030
Michael J. Tang, MD, 832-468-8895
Michael J. Tang
About this study
Official title: Inhalation Approaches to Nausea: A Randomized Controlled Trial
The goal of this research study is to understand the effect of inhalation approaches in reducing nausea in cancer patients.
Read the 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.
- Conditions
- Malignant Neoplasm
- Being tested
- Isopropyl Alcohol, Placebo, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isopropyl AlcoholDrug
Also called Isopropanol, Isopropanolol
Given via nasal inhalation
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given via nasal inhalation
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (isopropyl alcohol) | Experimental | Patients receive isopropyl alcohol via nasal inhalation. Receives: Drug: Isopropyl Alcohol; Other: Questionnaire Administration |
| Arm II (placebo) | Placebo comparator | Patients receive placebo via nasal inhalation. Receives: Other: Placebo; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 5 minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start5 Nov 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yvonne J Heung, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181463
- Sponsor's protocol ID
- 2019-0472
- Other IDs
- NCI-2019-07377, 2019-0472
- Status last verified
- May 2026
- First submitted
- 19 Nov 2019
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhalation Approaches to Nausea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04181463
- Acronym / sponsor ID
- 2019-0472
- Conditions
- Malignant Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (isopropyl alcohol) | Experimental | Drug: Isopropyl Alcohol, Other: Questionnaire AdministrationPatients receive isopropyl alcohol via nasal inhalation. |
| Arm II (placebo) | Placebo comparator | Other: Placebo, Other: Questionnaire AdministrationPatients receive placebo via nasal inhalation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isopropyl AlcoholAlso: Isopropanol, IsopropanololGiven via nasal inhalation | Drug | Arm I (isopropyl alcohol) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven via nasal inhalation | Other | Arm II (placebo) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (isopropyl alcohol), Arm II (placebo) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yvonne J Heung principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isopropyl Alcohol and Questionnaire Administration in people with Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael J Tang, MD ((832) 468-8895, MJTang@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nausea (time frame: Baseline up to 5 minutes post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.