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Symptom Management After Breast Cancer Surgery

Primary Purpose

Neuropathic Pain, Postmastectomy Pain

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Lidoderm patch

Placebo patch

About this trial

This is an interventional supportive care trial for Neuropathic Pain focused on measuring breast cancer, neuropathic pain, topical lidocaine, postmastectomy pain, breast symptoms, breast pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

UCSF Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lidocaine Patch

Placebo Patch

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pain Interference With Function

Full Information

NCT ID

NCT00686127

First Posted

May 27, 2008

Last Updated

April 27, 2018

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT00686127

Brief Title

Symptom Management After Breast Cancer Surgery

Official Title

A Randomized, Double-Blind, Placebo-Controlled Trial (RDBPCT) of the Effectiveness of the Lidocaine Patch in the Management of Neuropathic Pain After Breast Cancer Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain, Postmastectomy Pain

Keywords

breast cancer, neuropathic pain, topical lidocaine, postmastectomy pain, breast symptoms, breast pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine Patch

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo Patch

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lidoderm patch

Other Intervention Name(s)

Lidoderm, Lidoaine patch 5%

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo patch

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks

Description

Time Frame

Baseline, 12 weeks

Secondary Outcome Measure Information:

Title

Pain Interference With Function

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

UCSF Comprehensive Cancer Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

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Symptom Management After Breast Cancer Surgery

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