This trial studies how well nasal inhalation of isopropyl alcohol works for the treatment of nausea in patients with cancer. Isopropyl alcohol may treat nausea by affecting the neurological pathways involved in the vomiting reflex and/or the controlled breathing pattern required for inhalation.
Additional locations may be listed on ClinicalTrials.gov for NCT04181463.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Approved
Contact: Yvonne J. Heung
Phone: 713-792-6085
PRIMARY OBJECTIVE:
I. To compare the efficacy (change in the nausea level from baseline to 5 minutes post-intervention) between nasally inhaled isopropyl alcohol (IPA) and nasally inhaled saline solution (placebo) in the treatment of undifferentiated nausea among patients with cancer.
SECONDARY OBJECTIVES:
I. To assess patient-reported outcomes and satisfaction in IPA and placebo arms.
II. To evaluate the use of rescue anti-emetic medication administered from time 0 to 1 hour post-intervention between the two arms.
III. To evaluate the association between patients’ sociodemographic characteristics (e.g. age, sex, race/ethnicity, religion) and clinical factors (e.g. cancer diagnosis and stage, Edmonton Symptom Assessment Scale-Financial Distress and Spiritual Pain [ESAS-FS], Eastern Cooperative Oncology Group [ECOG] score, location of intervention, etc.) with improvement in nausea.
IV. To assess patient-reported outcomes 24 hours post-intervention of the two arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive isopropyl alcohol via nasal inhalation.
ARM II: Patients receive placebo via nasal inhalation.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorYvonne J. Heung
