Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

NCT04822597 | Completed Phase 3 Results FDA Drug FDA Device

• 6 other identifiers: 2021-0261A539713SMPH/SURGERY/SURG ONCUW20164Protocol Version 3/20222T32CA090217-16
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness four different pain treatments for the injection of radioactive tracer that women with breast cancer receive for sentinel lymph node biopsies. This study will include women who have been diagnosed with breast cancer and who will be undergoing sentinel lymph node biopsy with a standard injection of radioactive tracer before surgery. A participant's active participation will take place on two separate occasions. In the first occasion, a participant will complete a brief pain assessment on the day of enrollment. The rest of a participant's active participation will take place on one day (the day of surgery) and last approximately 20 minutes, after which active participation will end.

Conditions

Breast Cancer; Sentinel Lymph Node; Breast Neoplasms; Breast Cancer Female

Keywords

Sentinel Lymph Node Biopsy; Sentinel Lymph Node Mapping; Radioactive Tracer Injection; Nuclear Medicine; Radiocolloid Injection

Outcome Measures

Primary Outcomes (1)

• Median Post-Procedural Pain Score

  Post-procedural pain score on the Wong-Baker FACES scale. Scale from 0-10 with 0 being "no pain" and 10 being "worst pain".

  Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

Secondary Outcomes (13)

• Short Form McGill Sensory Pain Score

  Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

• Short Form McGill Affective Pain Score

  Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

• Short Form McGill VAS Pain Score

  Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

• Short Form McGill Combined Pain Score

  Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

• Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied

  Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection

Study Arms (4)

Ice Pack

ACTIVE COMPARATOR

Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)

Other: Ice pack

Lidocaine Patch

EXPERIMENTAL

A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection

Drug: Lidocaine patch

Buzzy(R)

EXPERIMENTAL

A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.

Device: Buzzy(R); Other: Ice pack

Lidocaine Patch and Buzzy(R)

EXPERIMENTAL

A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.

Drug: Lidocaine patch; Device: Buzzy(R); Other: Ice pack

Interventions

Lidocaine patch DRUG

Lidocaine is a local anesthetic.

Also known as: topical lidocaine 4%

Lidocaine Patch; Lidocaine Patch and Buzzy(R)

Buzzy(R) DEVICE

Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.

Also known as: vibrating distraction device, therapeutic vibrator

Buzzy(R); Lidocaine Patch and Buzzy(R)

Ice pack OTHER

Ice cools the skin and can provide some numbing for pain.

Also known as: ice, coolant

Buzzy(R); Ice Pack; Lidocaine Patch and Buzzy(R)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• greater than or equal to 18 years of age
• biopsy proven breast cancer
• standard radiotracer injection (intradermal injection in the upper outer quadrant of the involved breast)
• radiotracer injection occurs on the same day as sentinel lymph node surgery

You may not qualify if:

• males
• pregnancy
• local anesthetic allergy or active use of the following medications:
• Abametapir (risk X)
• Conivaptan (risk X)
• Fusidic Acid (risk X)
• Idelalisib (risk X)
• Mifepristone (risk D)
• Stiripentol (risk D)
• Amiodarone (risk C)
• Dofetilide (risk C)
• Dronedarone (risk C)
• Ibutilide (risk C)
• Sotalol (risk C)
• Vernakalant (risk C)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ice

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Results Point of Contact

• Title: Heather B Neuman, MD, MS, FACS
• Organization: University of Wisconsin School of Medicine and Public Health

neuman@surgery.wisc.edu

(608) 263-7064

Study Officials

• Heather B Neuman, MD

  University of Wisconsin Madison School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data will be analyzed with intervention arms masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be four separate treatment arms. Participants have equal chances of being assigned to any of the four arms.

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: April 23, 2021
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: August 3, 2023
• Results First Posted: August 3, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)