Symptom Management After Breast Cancer Surgery

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Postmastectomy Pain; Neuropathic Pain

Treatments: Drug: Placebo patch; Drug: Lidoderm patch

Study type: Interventional

Funder types: Other

Identifiers

NCT00686127

CA107091

Breast Pain

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

Lidocaine Patch

Active Comparator group

Description:

Drug: lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.

Treatment:

Drug: Lidoderm patch

Placebo Patch

Placebo Comparator group

Description:

Drug: placebo patch, 1 patch was applied topically to the affected site(s) for 12 hours each day.

Treatment:

Drug: Placebo patch