Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04181463
Other study ID # 2019-0472
Secondary ID NCI-2019-0737720
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 5, 2024
Est. completion date December 30, 2025

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact Yvonne J Heung
Phone 713-792-6085
Email yjheung@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 112
Est. completion date December 30, 2025
Est. primary completion date December 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Isopropyl Alcohol
Given via nasal inhalation
Other:
Placebo
Given via nasal inhalation
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Active, not recruiting NCT02243592 - Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment
Completed NCT03445572 - Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer N/A
Active, not recruiting NCT02860039 - High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant Phase 2
Completed NCT01946217 - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials N/A
Completed NCT01635413 - Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial) N/A
Completed NCT00026169 - Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure Phase 1
Recruiting NCT04534075 - Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial Phase 3
Active, not recruiting NCT01806129 - Reproductive Health Program in Patients With Cancer N/A
Recruiting NCT03915717 - Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
Recruiting NCT02280161 - Germ-Line Mutations in Blood and Saliva Samples From Patients With Cancer
Recruiting NCT05520281 - Short-term Psychodynamic Psychotherapy in Serious Physical Illness N/A
Terminated NCT00532064 - Cardiac Biomarkers in Early Detection of Cardiotoxicity in Patients Receiving Sunitinib or Sorafenib Chemotherapy
Completed NCT04990882 - FAPI PET/CT Prospective Interobserver Agreement
Completed NCT01896778 - Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer N/A
Recruiting NCT05770102 - DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Teenage/Young Adults and Paediatric Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition Phase 2/Phase 3
Recruiting NCT06090266 - A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT05886764 - Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials N/A
Completed NCT01506440 - Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy
Completed NCT01432431 - Spiritual Care in Improving Quality of Life of Patients, Caregivers, and Hospital Staff N/A

External Links