Vapocoolant Spray for Injection Pain in Breast Cancer Procedures

Overseen By Sanjit Tewari, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Diabetes, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cooling spray called Nüm to determine if it can reduce pain and anxiety during breast injections. The goal is to see if applying Nüm to the skin before the injection makes the experience more comfortable for patients. Adults undergoing a specific breast injection procedure can participate, provided they have no allergies to the spray or certain health conditions like diabetes.

As an unphased trial, this study allows patients to contribute to research that could enhance comfort during medical procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this vapocoolant spray is safe for reducing injection pain in breast cancer procedures?

Research has shown that the vapocoolant spray, Nüm, is generally safe and easy to use. In one study, 62% of participants expressed willingness to use it again. Only two individuals experienced minor skin redness, which resolved quickly. This indicates that most people find the spray comfortable to use. Overall, Nüm appears safe, with only a few mild side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Nüm Vapocoolant Spray because it offers a fast and non-invasive way to reduce injection pain, which is a common discomfort during breast cancer procedures. Unlike traditional anesthetics, which often involve injections themselves or take time to work, this spray acts instantly by cooling and numbing the skin upon contact. This method not only makes the procedure less painful but also more convenient, as it does not require additional equipment or lengthy preparation.

What evidence suggests that Nüm Vapocoolant is effective for reducing injection pain in breast cancer procedures?

Research has shown that Nüm vapocoolant spray, which participants in this trial will receive, can help reduce pain during injections. One study found that this spray significantly decreased pain for adults receiving a tube in a vein. Another study demonstrated that the spray effectively reduced pain during the first injection of anesthesia. These findings suggest that Nüm might also make breast injections less painful by numbing the skin. ^{1 2 3 6 7}

Who Is on the Research Team?

Sanjit Tewari, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are undergoing a breast lymphoscintigraphy injection, which helps stage breast cancer. It's open to those able to consent and includes pregnant or lactating women. People with uncontrolled illnesses like diabetes, mental health conditions affecting study compliance, or allergies to vapocoolants can't participate.

Inclusion Criteria

I am an adult scheduled for a specific breast lymph node mapping procedure.

Ability to understand and the willingness to sign a written informed consent document

Childbearing potential, lactating, pregnant women will be included

Exclusion Criteria

I do not have uncontrolled diabetes.

Patients with psychiatric illness/social situations that would limit compliance with study requirements

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Application of vapocoolant anesthetic spray to reduce pain/anxiety during breast lymphoscintigraphy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nüm

Trial Overview

The trial is testing if a cooling spray anesthetic called 'Nüm' can lessen the pain and anxiety when getting a breast injection for cancer staging. Participants will receive this vapocoolant before their scheduled procedure.

How Is the Trial Designed?

Group I: num Vapocoolant Experimental Treatment 1 Intervention

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

Nüm is already approved in United States for the following indications:

Approved in United States as Nüm for:

• Minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses)
• Injections (venipuncture, IV starts)
• Temporary relief of minor sports injuries

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Gilero, LLC

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

A randomized double-blind trial involving 201 adults showed that a topical alkane vapocoolant significantly reduced pain during intravenous cannulation, with median pain scores of 12 mm for the vapocoolant group compared to 36 mm for the control group (P<0.001).

The vapocoolant was found to be safe and well-accepted, with 62% of patients preferring it for future use, and only two cases of transient skin redness reported at follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. Hijazi, R., Taylor, D., Richardson, J.[2021]

In a study involving 90 infants receiving their first wDPT vaccination, the use of EMLA cream or vapocoolant spray alongside breastfeeding did not significantly reduce the duration of crying after vaccination compared to breastfeeding alone.

However, both EMLA and vapocoolant spray resulted in significantly lower pain scores, indicating they may effectively reduce perceived pain during vaccination, warranting further research into their use as pain relief methods for infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of topical EMLA and vapocoolant spray for reducing pain during wDPT vaccination. Gupta, NK., Upadhyay, A., Dwivedi, AK., et al.[2018]

In a study of 30 patients undergoing breast lymphoscintigraphy, the use of vapocoolant analgesia resulted in a successful procedure rate of 100% and an average self-reported pain score of only 1.98, indicating low pain levels during the injection process.

The application of vapocoolant did not compromise the effectiveness of lymphoscintigraphy, suggesting it is a feasible option for reducing pain in this procedure for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vapocoolant Analgesia for Breast Lymphoscintigraphy: A Prospective Clinical Trial. Tewari, SO., Tamirisa, N., Xu, G., et al.[2023]

In a study involving 52 patients, the use of vapocoolants significantly reduced pain during cosmetic botulinum injections compared to no treatment, with a p-value of less than 0.001 indicating strong statistical significance.

Approximately 67% of patients reported that vapocoolants caused less pain than no anesthesia, and 54% preferred this method for future treatments, highlighting its efficacy in improving patient comfort and reducing anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of pain and anxiety prior to botulinum toxin injections with a new topical anesthetic method. Weiss, RA., Lavin, PT.[2018]

In a study involving 88 young male blood donors, the use of vapocoolant spray significantly reduced pain during venipuncture, with an average pain score of 1.90 for the spray group compared to 3.23 for the control group (P = .02).

The results indicate that vapocoolant spray is an effective pain management technique for blood donation, enhancing the comfort of donors during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors: A Randomized Controlled Trial. Basak, T., Aciksoz, S., Savasci, U., et al.[2021]

In a study involving 50 rats, the use of vapocoolant sprays showed no significant changes in vessel diameter or capillary density, indicating that these sprays are safe for microcirculation during minor medical procedures.

Despite initial decreases in vessel diameter and capillary density, the overall lack of significant changes in inflammatory markers suggests that vapocoolant sprays do not adversely affect cutaneous blood flow or induce inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microcirculatory effect of topical vapocoolants. Galdyn, I., Swanson, E., Gordon, C., et al.[2020]

In a study involving 30 subjects (15 receiving filler injections and 15 receiving neurotoxin injections), the use of vapocoolant spray significantly reduced perceived pain during cosmetic facial procedures, with a 59% decrease for neurotoxin and a 64% decrease for filler injections.

The results were statistically significant (P < .05), indicating that vapocoolant technology is an effective method to enhance patient comfort during minimally invasive cosmetic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vapocoolant Anesthesia for Cosmetic Facial Rejuvenation Injections: A Randomized, Prospective, Split-Face Trial. Zeiderman, MR., Kelishadi, SS., Tutela, JP., et al.[2020]

Vapocoolant sprays are used to manage pain during the access of totally implanted venous access devices (TIVADs), but there is currently no clear indication or contraindication for their use, highlighting a gap in clinical guidelines.

The article aims to evaluate the safety and effectiveness of vapocoolant sprays in the TIVAD access process, emphasizing the need for best practices that consider product use, institutional policies, and individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vapocoolant Sprays: Use With Totally Implanted Venous Access Devices. Bostelman, C.[2019]

In a study involving 220 adult patients, the topical vapocoolant alkane spray resulted in significantly less pain during the administration of the anesthetic compared to 1% lidocaine (0 mm vs 11 mm), and it also led to lower pain scores during the actual cannulation (9 mm vs 0 mm).

The vapocoolant spray demonstrated higher success rates for cannulation (83.6% vs 67.3%) and required less time to administer (9 seconds vs 84.5 seconds), making it a more convenient option for healthcare providers in emergency settings, despite slightly less effectiveness in pain reduction compared to lidocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vapocoolant spray vs subcutaneous lidocaine injection for reducing the pain of intravenous cannulation: a randomized, controlled, clinical trial. Page, DE., Taylor, DM.[2022]

Citations

1.

withpower.com

withpower.com/trial/phase-breast-cancer-2-2023-49026

Vapocoolant Spray for Injection Pain in Breast Cancer ...

A randomized double-blind trial involving 201 adults showed that a topical alkane vapocoolant significantly reduced pain during intravenous cannulation, with ...

2.

tech.snmjournals.org

tech.snmjournals.org/content/52/2/104

Vapocoolant Analgesia for Breast Lymphoscintigraphy

Results: The lymposcintigraphy procedure was successful in 100% of cases with an ipsilateral axillary node identified on average within 2.4 h of ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11149591/

Vapocoolant Analgesia for Breast Lymphoscintigraphy

Results: The lymposcintigraphy procedure was successful in 100% of cases with an ipsilateral axillary node identified on average within 2.4 h of ...

4.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-01629

Vapocoolant Analgesia (Num) for the Prevention of Pain ...

This clinical trial tests how well Num vapocoolant works to prevent the pain associated with lymphoscintigraphy.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26162573/

Application of a topical vapocoolant spray decreases pain ...

Application of topical vapocoolant spray was shown to significantly decrease pain at the site of initial intradermal anaesthetic injection as compared to ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf20/K202782.pdf

December 21, 2020 623 Medical, LLC James Fentress ...

nüm is a sterile topical anesthetic spray – vapocoolant (skin refrigerant) intended for topical application to control pain associated with ...

7.

careacross.com

careacross.com/clinical-trials/trial/NCT05744557

Vapocoolant Analgesia for Breast Lymphoscintigraphy

Demonstrate safety of topical vapocoolant in the setting of breast lymphoscintigraphy. Secondary Objectives: 1. To assess patient pain intensity associated with ...