Nasal Inhalation of Isopropyl Alcohol for the Treatment of Nausea in Patients With Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

The goal of this research study is to understand the effect of inhalation approaches in reducing nausea in cancer patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Isopropyl Alcohol

    Drug

    Given via nasal inhalation

  • Placebo

    Other intervention

    Given via nasal inhalation

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: Arm I (isopropyl alcohol)Experimental treatment 2 interventions
Group B: Arm II (placebo)Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline up to 5 minutes post-intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: