NCT05744557

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

2.2 years

First QC Date

February 15, 2023

Last Update Submit

May 15, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (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.

Study Arms (1)

num Vapocoolant

EXPERIMENTAL

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

Interventions

num VapocoolantOTHER

Spray will be administered for 4 to 6 seconds from a distance of 3 to 6 inches to desired sites of skin

num Vapocoolant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sanjit Tewari, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 27, 2023

Study Start

March 1, 2023

Primary Completion

May 13, 2025

Study Completion

May 13, 2025

Last Updated

May 20, 2025

Record last verified: 2025-05

Locations

US(1)