Vapocoolant Analgesia for Breast Lymphoscintigraphy

Breast Cancer Clinical Trial

Official title:

Vapocoolant Analgesia for Breast Lymphoscintigraphy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05744557
• Other study ID #: 2022-0454
• Secondary ID: NCI-2023-01629
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Sanjit Tewari, MD
• Phone: 832-729-1874
• Email: sotewari[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Primary Objectives:

1. Establish feasibility of topical vapocoolant in the setting of breast lymphoscintigraphy.

2. Demonstrate safety of topical vapocoolant in the setting of breast lymphoscintigraphy.

Secondary Objectives:

1. To assess patient pain intensity associated with the performance of breast lymphoscintigraphy.

2. To evaluate the attitude from patients about supporting the continued offering of topical vapocoolant in the breast lymphoscintigraphy clinic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• num Vapocoolant
Spray will be administered for 4 to 6 seconds from a distance of 3 to 6 inches to desired sites of skin

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Gilero, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0		through study completion; an average of 1 year.

External Links

•   MD Anderson Cancer Center