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Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04822597
Recruitment Status : Completed
First Posted : March 30, 2021
Last Update Posted : July 18, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Sentinel Lymph Node Breast Neoplasms Breast Cancer Female Drug: Lidocaine patch Device: Buzzy(R) Other: Ice pack Phase 3

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:

  1. To assess patient satisfaction with pain control modality for radiotracer injection.
  2. To identify barriers to implementation of the different pain control interventions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There will be four separate treatment arms. Participants have equal chances of being assigned to any of the four arms.
Masking: Single (Outcomes Assessor)
Masking Description: Data will be analyzed with intervention arms masked.
Primary Purpose: Supportive Care
Official Title: Optimizing Topical Pain Control for Breast Cancer Patients Undergoing Pre-operative Radiotracer Injection for Sentinel Lymph Node Mapping
Actual Study Start Date : April 23, 2021
Actual Primary Completion Date : May 9, 2022
Actual Study Completion Date : May 9, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ice Pack
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
Other: Ice pack
Ice cools the skin and can provide some numbing for pain.
Other Names:
  • ice
  • coolant

Experimental: Lidocaine Patch
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection
Drug: Lidocaine patch
Lidocaine is a local anesthetic.
Other Name: topical lidocaine 4%

Experimental: Buzzy(R)
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
Device: Buzzy(R)
Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
Other Names:
  • vibrating distraction device
  • therapeutic vibrator

Other: Ice pack
Ice cools the skin and can provide some numbing for pain.
Other Names:
  • ice
  • coolant

Experimental: Lidocaine Patch and Buzzy(R)
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
Lidocaine is a local anesthetic.
Other Name: topical lidocaine 4%

Device: Buzzy(R)
Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
Other Names:
  • vibrating distraction device
  • therapeutic vibrator

Other: Ice pack
Ice cools the skin and can provide some numbing for pain.
Other Names:
  • ice
  • coolant




Primary Outcome Measures :
  1. Mean Post-Procedural Pain Score [ Time Frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection ]
    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 :
  1. Short Form McGill Sensory Pain score [ Time Frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection ]
    Sensory pain score out of 33 with 0 being "no pain" and 33 being severe sensory pain

  2. Short Form McGill Affective Pain score [ Time Frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection ]
    Affective pain score out of 12 with 0 being "no pain" and 12 being severe affective pain

  3. Short Form McGill VAS Pain score [ Time Frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection ]
    Visual analog scale pain score out of 10 with zero being "no pain" and 10 being "worst possible pain"

  4. Short Form McGill Combined Pain score [ Time Frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection ]
    Combination of outcomes 2-4. Additive total score between 0 and 55 with zero being "no pain" and 55 being "severe pain"

  5. Degree of participant satisfaction with attention paid to complaints [ Time Frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection ]
    1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied"

  6. Degree of participant satisfaction with care provided during injection [ Time Frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection ]
    1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied"

  7. Degree of participant satisfaction with pain control [ Time Frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection ]
    1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied"

  8. Degree of anxiety during the injection [ Time Frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection ]
    1-4 scale with 1 being "very anxious" and 4 being "not at all anxious"

  9. Recommendation of pain control modality [ Time Frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection ]
    "Yes", "No", "Not sure" with option for free response

  10. Provider perceived ease of administration [ Time Frame: Day of surgery (last of two study visits), assessed within 30 minutes of radioactive tracer injection ]
    7 point single ease question to rate ease of a task. 1 being "very difficult" and 7 being "very easy"

  11. Provider perceived participant pain [ Time Frame: Day of surgery, assessed within 30 minutes of radioactive tracer injection ]
    11 point numeric rating scale for perceived pain of others. 0 being "no pain" and 7-10 being "severe pain".

  12. Rank ordering ease of use of interventions [ Time Frame: Last participant off study, up to 1 year ]
    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".

  13. Rank ordering perceived efficacy of interventions [ Time Frame: Last participant off study, up to 1 year ]
    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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04822597


Locations
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United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Heather B Neuman, MD University of Wisconsin Madison School of Medicine and Public Health
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Informed Consent Form  [PDF] April 7, 2021

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04822597    
Other Study ID Numbers: 2021-0261
A539713 ( Other Identifier: UW Madison )
SMPH/SURGERY/SURG ONC ( Other Identifier: UW Madison )
UW20164 ( Other Identifier: UWCCC )
Protocol Version 3/2022 ( Other Identifier: UW Madison )
2T32CA090217-16 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Wisconsin, Madison:
Sentinel Lymph Node Biopsy
Sentinel Lymph Node Mapping
Radioactive Tracer Injection
Nuclear Medicine
Radiocolloid Injection
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action