Breast CancerPhase 3NCT04822597
Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer
A Phase 3 study testing Lidocaine patch, Buzzy(R) and Ice pack in people with Breast Cancer and Sentinel Lymph Node, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Sentinel Lymph Node, Breast Neoplasms
- What is being tested?
- Lidocaine patch, Buzzy(R) and Ice pack
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2021to 9 May 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- males
- pregnancy
- local anesthetic allergy or active use of the following medications:
- Abametapir (risk X)
- Conivaptan (risk X)
- Fusidic Acid (risk X)
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Optimizing Topical Pain Control for Breast Cancer Patients Undergoing Pre-operative Radiotracer Injection for Sentinel Lymph Node Mapping
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.
Read the 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.
- Being tested
- Lidocaine patch, Buzzy(R), Ice pack
- Keywords
- Sentinel Lymph Node Biopsy, Sentinel Lymph Node Mapping, Radioactive Tracer Injection, Nuclear Medicine, Radiocolloid Injection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine patchDrug
Also called topical lidocaine 4%
Lidocaine is a local anesthetic.
Buzzy(R)Device
Also called vibrating distraction device, therapeutic vibrator
Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
Ice packOther
Also called ice, coolant
Ice cools the skin and can provide some numbing for pain.
| Study group | Role | What they receive |
|---|---|---|
| Ice Pack | Active comparator | Ice will be placed on the breast prior to radioactive tracer injection (usual treatment) Receives: 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 Receives: 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. Receives: 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. Receives: Drug: Lidocaine patch; Device: Buzzy(R); Other: Ice pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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
Sensory pain score out of 33 with 0 being "no pain" and 33 being severe sensory pain
Measured: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Short Form McGill Affective Pain Score
Affective pain score out of 12 with 0 being "no pain" and 12 being severe affective pain
Measured: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
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"
Measured: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
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"
Measured: 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
1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.
Measured: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
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.
Measured: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
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.
Measured: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
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".
Measured: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered "Yes"
"Yes", "No", "Not sure" with option for free response
Measured: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
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.
Measured: Day of surgery (last of two study visits), assessed within 30 minutes of radioactive tracer injection
Provider Perceived Participant Pain
11 point numeric rating scale for perceived pain of others. 0 being "no pain" and 7-10 being "severe pain".
Measured: Day of surgery, assessed within 30 minutes of radioactive tracer injection
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".
Measured: Assessed after last participant off study (up to 12.5 months)
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".
Measured: Assessed after last participant off study (up to 12.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start23 Apr 2021
- Primary completion9 May 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be four separate treatment arms. Participants have equal chances of being assigned to any of the four arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heather B Neuman, MD, Principal investigator, University of Wisconsin Madison School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822597
- Sponsor's protocol ID
- 2021-0261
- Other IDs
- A539713, SMPH/SURGERY/SURG ONC, UW20164, Protocol Version 3/2022, 2T32CA090217-16
- Status last verified
- Jul 2023
- First submitted
- 26 Mar 2021
- Last updated
- 3 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Topical Pain Control for Breast Cancer Patients Undergoing Pre-operative Radiotracer Injection for Sentinel Lymph Node Mapping
- ClinicalTrials.gov ID
- NCT04822597
- Acronym / sponsor ID
- 2021-0261
- Keywords
- Sentinel Lymph Node Biopsy, Sentinel Lymph Node Mapping, Radioactive Tracer Injection, Nuclear Medicine, Radiocolloid Injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Posted 3 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- There will be four separate treatment arms. Participants have equal chances of being assigned to any of the four arms.
| Arm | Type | Receives |
|---|---|---|
| Ice Pack | Active comparator | Other: Ice packIce will be placed on the breast prior to radioactive tracer injection (usual treatment) |
| Lidocaine Patch | Experimental | Drug: Lidocaine patchA lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection |
| Buzzy(R) | Experimental | Device: Buzzy(R), Other: Ice packA vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection. |
| Lidocaine Patch and Buzzy(R) | Experimental | Drug: Lidocaine patch, Device: Buzzy(R), Other: Ice packA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- males
- pregnancy
- local anesthetic allergy or active use of the following medications:
- Non-English speaking/reading
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine patchAlso: topical lidocaine 4%Lidocaine is a local anesthetic. | Drug | Lidocaine Patch, Lidocaine Patch and Buzzy(R) |
| Buzzy(R)Also: vibrating distraction device, therapeutic vibratorBuzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations. | Device | Buzzy(R), Lidocaine Patch and Buzzy(R) |
| Ice packAlso: ice, coolantIce cools the skin and can provide some numbing for pain. | Other | Buzzy(R), Ice Pack, Lidocaine Patch and Buzzy(R) |
Primary outcome
Median 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".
13 secondary outcomes
Short Form McGill Sensory Pain Score
Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Short Form McGill Affective Pain Score
Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Short Form McGill VAS Pain Score
Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Short Form McGill Combined Pain Score
Time frame: 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
Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied
Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied
Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious
Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered "Yes"
Time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Provider Perceived Ease of Administration
Time frame: Day of surgery (last of two study visits), assessed within 30 minutes of radioactive tracer injection
Provider Perceived Participant Pain
Time frame: Day of surgery, assessed within 30 minutes of radioactive tracer injection
Provider Rank Ordering Ease of Use of Interventions
Time frame: Assessed after last participant off study (up to 12.5 months)
Provider Rank Ordering Perceived Efficacy of Interventions
Time frame: Assessed after last participant off study (up to 12.5 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather B Neuman, MD principal investigator
University of Wisconsin Madison School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine patch, Buzzy(R) and Ice pack in people with Breast Cancer and Sentinel Lymph Node, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Post-Procedural Pain Score (time frame: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.