- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05744557
Vapocoolant Analgesia for Breast Lymphoscintigraphy
October 3, 2023 updated by: M.D. Anderson Cancer Center
To learn if applying vapocoolant anesthetic spray ("Nüm") on the surface of the intended injection site will reduce the pain/anxiety associated with breast injections.
Study Overview
Detailed Description
Primary Objectives:
- Establish feasibility of topical vapocoolant in the setting of breast lymphoscintigraphy.
- Demonstrate safety of topical vapocoolant in the setting of breast lymphoscintigraphy.
Secondary Objectives:
- To assess patient pain intensity associated with the performance of breast lymphoscintigraphy.
- To evaluate the attitude from patients about supporting the continued offering of topical vapocoolant in the breast lymphoscintigraphy clinic.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sanjit Tewari, MD
- Phone Number: 832-729-1874
- Email: sotewari@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
-
Contact:
- Sanjit Tewari, MD
- Phone Number: 832-729-1874
- Email: sotewari@mdanderson.org
-
Principal Investigator:
- Sanjit Tewari, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Any adult patient undergoing asubareolar breast lymphoscintigraphy injection will be eligible.
- Age ≥18 years old
- Ability to understand and the willingness to sign a written informed consent document.
- Childbearing potential, lactating, pregnant women will be included.
Exclusion Criteria:
- Patients who have allergy or had prior hypersensitivity to either of the vapocoolants including 1,1,1,3,3 Pentafluoropropane and 1,1,1,2-Tetrafluoroethane.
- Patients with uncontrolled intercurrent illness (insulin dependent and non-insulin dependent diabetes)
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: num Vapocoolant
vapocoolant anesthetic spray (a spray that cools and numbs the skin) to control pain during minor surgical procedures (such as lancing boils, incisions, injections and IV placements) and minor sport injuries
|
Spray will be administered for 4 to 6 seconds from a distance of 3 to 6 inches to desired sites of skin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time Frame: through study completion; an average of 1 year.
|
through study completion; an average of 1 year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sanjit Tewari, MD, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Estimated)
April 30, 2025
Study Completion (Estimated)
April 30, 2025
Study Registration Dates
First Submitted
February 15, 2023
First Submitted That Met QC Criteria
February 23, 2023
First Posted (Actual)
February 27, 2023
Study Record Updates
Last Update Posted (Actual)
October 5, 2023
Last Update Submitted That Met QC Criteria
October 3, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2022-0454
- NCI-2023-01629 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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