Vapocoolant Analgesia for Breast Lymphoscintigraphy

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05744557
• Collaborator: Gilero, LLC (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: num Vapocoolant	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vapocoolant Analgesia for Breast Lymphoscintigraphy
• Actual Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Aug 31, 2023

Arms and Interventions

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	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

Outcome Measures

Primary Outcome Measures

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• Gilero, LLC

Investigators

• Principal Investigator: Sanjit Tewari, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MD Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05744557
• Other Study ID Numbers: 2022-0454; NCI-2023-01629
• First Posted: Feb 27, 2023
• Last Update Posted: Mar 2, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 2, 2023