Vapocoolant Analgesia for Breast Lymphoscintigraphy | NCT05744557

Studies
Vapocoolant Analgesia for Breast Lymphoscintigraphy

NCT05744557

Sponsor

M.D. Anderson Cancer Center

Status

Terminated

Last Update Posted

May 20, 2025Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

num Vapocoolant

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2023-01629	Other Identifier	NCI-CTRP Clinical Trials Registry

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

<75% accrued participants

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

May 13, 2025Actual

Completion Date

May 13, 2025Actual

First Submitted Date

Feb 15, 2023

First Submission Date that Met QC Criteria

Feb 23, 2023

First Posted Date

Feb 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2025

Last Update Posted Date

May 20, 2025Actual

Name	Class
Gilero, LLC	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
num Vapocoolant	Other	Spray will be administered for 4 to 6 seconds from a distance of 3 to 6 inches to desired sites of skin	num Vapocoolant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sanjit Tewari, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MD Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
MD Anderson Cancer Center	View source

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Jul 6, 2023	May 15, 2025	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided