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| ID | Type | Description | Link |
|---|---|---|---|
| CA107091 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine Patch | Active Comparator | Drug: lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day. |
|
| Placebo Patch | Placebo Comparator | Drug: placebo patch, 1 patch was applied topically to the affected site(s) for 12 hours each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidoderm patch | Drug | 1 patch was applied topically to the affected site(s) for 12 hours each day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference With Function | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Comprehensive Cancer Center | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine Patch | Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day. |
| FG001 | Placebo Patch | Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine Patch | Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day. |
| BG001 | Placebo Patch |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Number | units on a scale | Baseline, 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine Patch | Lidocaine patch One patch is changed every twenty-four hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christine Miaskowski, PI | University of California, San Francisco | 415-476-9407 | chris.miaskowski@nursing.ucsf.edu |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D001943 | Breast Neoplasms |
| D059373 | Mastodynia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C511998 | Lidoderm |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo patch | Drug | 1 patch was applied topically to the affected site(s) for 12 hours each day. |
|
Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Average pain intensity | Patients scored their pain intensity in the breast and/or ipsilateral arm at enrollment using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10) | Mean | Standard Deviation | units on a scale |
|
| Worst pain intensity | Patients scored their pain intensity in the breast and/or ipsilateral arm at enrollment using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10) | Mean | Standard Deviation | units on a scale |
|
| OG001 | Placebo Patch | Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day. |
|
|
| Secondary | Pain Interference With Function | Not Posted | 12 weeks | Participants |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Placebo Patch | Placebo patch: Patch is changed every 24 hours | 0 | 7 | 0 | 7 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Aniline Compounds |
| D000588 | Amines |