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Trial Title:
Vapocoolant Analgesia for Breast Lymphoscintigraphy
NCT ID:
NCT05744557
Condition:
Breast Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
num Vapocoolant
Description:
Spray will be administered for 4 to 6 seconds from a distance of 3 to 6 inches to desired
sites of skin
Arm group label:
num Vapocoolant
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sanjit Tewari, MD
Phone:
832-729-1874
Email:
sotewari@mdanderson.org
Contact backup:
Last name:
Sanjit Tewari, MD
Start date:
March 1, 2023
Completion date:
April 30, 2025
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
Gilero, LLC
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05744557
http://www.mdanderson.org
