Symptom Management After Breast Cancer Surgery

NCT ID: NCT00686127

Last Updated: 2018-06-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neuropathic Pain Postmastectomy Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Lidocaine Patch

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

Group Type ACTIVE_COMPARATOR

Lidoderm patch

Intervention Type DRUG

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

Placebo Patch

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

Group Type PLACEBO_COMPARATOR

Placebo patch

Intervention Type DRUG

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

Interventions

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Lidoderm patch

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

Intervention Type DRUG

Placebo patch

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

Intervention Type DRUG

Other Intervention Names

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Lidoderm, Lidoaine patch 5%

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCSF Comprehensive Cancer Center

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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CA107091

Identifier Type: -

Identifier Source: secondary_id

Breast Pain

Identifier Type: -

Identifier Source: org_study_id

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