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Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

Primary Purpose

Breast Cancer, Sentinel Lymph Node, Breast Neoplasms

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lidocaine patch
Buzzy(R)
Ice pack
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Sentinel Lymph Node Biopsy, Sentinel Lymph Node Mapping, Radioactive Tracer Injection, Nuclear Medicine, Radiocolloid Injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Non-English speaking/reading
  • Unable to provide informed consent
  • Unable to participate with surveys

  • Undergoing radiotracer injection the day prior to surgery or intra-operatively at the time of initial surgical scheduling

    • If patients are initially scheduled for same-day preoperative injection, complete all enrollment procedures (including randomization), and surgery is re-scheduled for a day prior to surgery or for intra-operative injection, they will be excluded if:

      • randomized to a lidocaine patch arm (Arms C or D)
      • re-scheduled for an intra-operative injection • Planned non-standard radiotracer injection site

Sites / Locations

  • University of Wisconsin School of Medicine and Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Ice Pack

Lidocaine Patch

Buzzy(R)

Lidocaine Patch and Buzzy(R)

Arm Description

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

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

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

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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Short Form McGill Sensory Pain Score
Sensory pain score out of 33 with 0 being "no pain" and 33 being severe sensory pain
Short Form McGill Affective Pain Score
Affective pain score out of 12 with 0 being "no pain" and 12 being severe affective pain
Short Form McGill VAS Pain Score
Visual analog scale pain score out of 100 with zero being "no pain" and 100 being "worst possible pain"
Short Form McGill Combined Pain Score
Combination of outcomes 2-3. Additive total score between 0 and 45 with zero being "no pain" and 45 being "severe pain"
Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied
1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.
Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied
1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.
Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied
1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.
Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious
1-4 scale with 1 being "very anxious" and 4 being "not at all anxious", reported here are the number of participants rating anxiety at 2 or "moderate".
Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered "Yes"
"Yes", "No", "Not sure" with option for free response
Provider Perceived Ease of Administration
7 point single ease question to rate ease of a task. 1 being "very difficult" and 7 being "very easy". This is the provider's perception of the how easy the intervention was to administer.
Provider Perceived Participant Pain
11 point numeric rating scale for perceived pain of others. 0 being "no pain" and 7-10 being "severe pain".
Provider Rank Ordering Ease of Use of Interventions
End of study survey to compare providers' perceived usability of intervention. Rank ordering of interventions 1-4 with 1 being "easiest to administer" and 4 being "hardest to administer".
Provider Rank Ordering Perceived Efficacy of Interventions
End of study survey to compare providers' perceived efficacy of intervention. Rank ordering of interventions 1-4 with 1 being "best pain control" and 4 being "least pain control".

Full Information

First Posted
March 26, 2021
Last Updated
July 11, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04822597
Brief Title
Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer
Official Title
Optimizing Topical Pain Control for Breast Cancer Patients Undergoing Pre-operative Radiotracer Injection for Sentinel Lymph Node Mapping
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 23, 2021 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
May 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Primary Objective: To test the effectiveness of four alternative approaches to topical anesthesia on pain associated with radiotracer injection for women diagnosed with breast cancer undergoing sentinel lymph node mapping. Secondary Objectives: To assess patient satisfaction with pain control modality for radiotracer injection. To identify barriers to implementation of the different pain control interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
There will be four separate treatment arms. Participants have equal chances of being assigned to any of the four arms.
Masking
Outcomes Assessor
Masking Description
Data will be analyzed with intervention arms masked.
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ice Pack
Arm Type
Active Comparator
Arm Description
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
Arm Title
Lidocaine Patch
Arm Type
Experimental
Arm Description
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection
Arm Title
Buzzy(R)
Arm Type
Experimental
Arm Description
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
Arm Title
Lidocaine Patch and Buzzy(R)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine patch
Other Intervention Name(s)
topical lidocaine 4%
Intervention Description
Lidocaine is a local anesthetic.
Intervention Type
Device
Intervention Name(s)
Buzzy(R)
Other Intervention Name(s)
vibrating distraction device, therapeutic vibrator
Intervention Description
Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
Intervention Type
Other
Intervention Name(s)
Ice pack
Other Intervention Name(s)
ice, coolant
Intervention Description
Ice cools the skin and can provide some numbing for pain.
Primary Outcome Measure Information:
Title
Median Post-Procedural Pain Score
Description
Post-procedural pain score on the Wong-Baker FACES scale. Scale from 0-10 with 0 being "no pain" and 10 being "worst pain".
Time Frame
Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Secondary Outcome Measure Information:
Title
Short Form McGill Sensory Pain Score
Description
Sensory pain score out of 33 with 0 being "no pain" and 33 being severe sensory pain
Time Frame
Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Title
Short Form McGill Affective Pain Score
Description
Affective pain score out of 12 with 0 being "no pain" and 12 being severe affective pain
Time Frame
Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Title
Short Form McGill VAS Pain Score
Description
Visual analog scale pain score out of 100 with zero being "no pain" and 100 being "worst possible pain"
Time Frame
Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Title
Short Form McGill Combined Pain Score
Description
Combination of outcomes 2-3. Additive total score between 0 and 45 with zero being "no pain" and 45 being "severe pain"
Time Frame
Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Title
Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied
Description
1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.
Time Frame
Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Title
Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied
Description
1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.
Time Frame
Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Title
Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied
Description
1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.
Time Frame
Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Title
Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious
Description
1-4 scale with 1 being "very anxious" and 4 being "not at all anxious", reported here are the number of participants rating anxiety at 2 or "moderate".
Time Frame
Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Title
Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered "Yes"
Description
"Yes", "No", "Not sure" with option for free response
Time Frame
Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Title
Provider Perceived Ease of Administration
Description
7 point single ease question to rate ease of a task. 1 being "very difficult" and 7 being "very easy". This is the provider's perception of the how easy the intervention was to administer.
Time Frame
Day of surgery (last of two study visits), assessed within 30 minutes of radioactive tracer injection
Title
Provider Perceived Participant Pain
Description
11 point numeric rating scale for perceived pain of others. 0 being "no pain" and 7-10 being "severe pain".
Time Frame
Day of surgery, assessed within 30 minutes of radioactive tracer injection
Title
Provider Rank Ordering Ease of Use of Interventions
Description
End of study survey to compare providers' perceived usability of intervention. Rank ordering of interventions 1-4 with 1 being "easiest to administer" and 4 being "hardest to administer".
Time Frame
Assessed after last participant off study (up to 12.5 months)
Title
Provider Rank Ordering Perceived Efficacy of Interventions
Description
End of study survey to compare providers' perceived efficacy of intervention. Rank ordering of interventions 1-4 with 1 being "best pain control" and 4 being "least pain control".
Time Frame
Assessed after last participant off study (up to 12.5 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) Non-English speaking/reading Unable to provide informed consent Unable to participate with surveys Undergoing radiotracer injection the day prior to surgery or intra-operatively at the time of initial surgical scheduling If patients are initially scheduled for same-day preoperative injection, complete all enrollment procedures (including randomization), and surgery is re-scheduled for a day prior to surgery or for intra-operative injection, they will be excluded if: randomized to a lidocaine patch arm (Arms C or D) re-scheduled for an intra-operative injection • Planned non-standard radiotracer injection site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather B Neuman, MD
Organizational Affiliation
University of Wisconsin Madison School of Medicine and Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

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