Neuropathic Pain, Postmastectomy Pain
Conditions
Keywords
breast cancer, neuropathic pain, topical lidocaine, postmastectomy pain, breast symptoms, breast pain
Brief summary
This trial is part of a larger, longitudinal study of symptoms that occur in the breast surgical scar area and/or ipsilateral arm following breast cancer surgery. Women who develop pain in the breast scar area or ipsilateral arm will be randomized to a placebo patch or a lidocaine patch that they will wear on a daily basis for 12 weeks. We hypothesize that women who wear the lidocaine patch will report a decrease in pain and decreased interference with function compared to women who wear the placebo patch.
Interventions
DRUGLidoderm patch
1 patch was applied topically to the affected site(s) for 12 hours each day.
DRUGPlacebo patch
1 patch was applied topically to the affected site(s) for 12 hours each day.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult women \>18 years who develop neuropathic pain in the breast scar area and/or ipsilateral arm following breast cancer surgery * Has a healed incision(s) * Has no recurrent disease in the painful area * Is able to read, write and understand English
Exclusion criteria
* Presence of another type of pain that is more severe than the neuropathic pain * Use of an opioid analgesic of greater than 60 mg codeine/day * Is actively trying to become pregnant * Has a medical contraindication to the use of lidocaine * Has an allergy to lidocaine * Is taking a coanalgesic for neuropathic pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks | Baseline, 12 weeks | Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline). |
Secondary
| Measure | Time frame |
|---|---|
| Pain Interference With Function | 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Patch Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day. | 14 |
| Placebo Patch Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day. | 7 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 14 | 6 |
Baseline characteristics
| Characteristic | Lidocaine Patch | Placebo Patch | Total |
|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 10.3 | 46.1 years STANDARD_DEVIATION 13.5 | 49.5 years STANDARD_DEVIATION 11.4 |
| Average pain intensity | 5.3 units on a scale STANDARD_DEVIATION 2.3 | 4.2 units on a scale STANDARD_DEVIATION 1.1 | 4.8 units on a scale STANDARD_DEVIATION 1.9 |
| Race/Ethnicity, Customized Asian/Pacific Islander | 1 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Black | 3 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Hispanic or Mixed Ethnic Background | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized White | 9 participants | 2 participants | 11 participants |
| Region of Enrollment United States | 14 participants | 7 participants | 21 participants |
| Sex: Female, Male Female | 14 Participants | 7 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Worst pain intensity | 7.8 units on a scale STANDARD_DEVIATION 1.5 | 6.4 units on a scale STANDARD_DEVIATION 4.8 | 7.1 units on a scale STANDARD_DEVIATION 3.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 7 |
| serious Total, serious adverse events | 0 / 14 | 0 / 7 |
Outcome results
Primary
Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks
Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).
Time frame: Baseline, 12 weeks
Population: This study attempted to evaluate changes in average pain intensity following breast cancer surgery. However, since none of the patients in the lidocaine group completed the 12 week trial, the outcomes of this study cannot be evaluated.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Placebo Patch | Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks | 4.0 units on a scale | 0 |
Secondary
Pain Interference With Function
Time frame: 12 weeks