Vapocoolant Analgesia for Breast Lymphoscintigraphy

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Other: num Vapocoolant

• Registration Number: NCT05744557
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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 Timeline

• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-02-27
• Study Start: 2023-03-01
• Status Verified: 2025-05
• Primary Completion: 2025-05-13
• Study Completion: 2025-05-13
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
num Vapocoolant	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States