Trial Outcomes & Findings for Symptom Management After Breast Cancer Surgery (NCT NCT00686127)

Last Updated: 2018-06-28

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2018-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	Lidocaine Patch 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 patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
Overall Study STARTED	14	7
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	14	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Lidocaine Patch 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 patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
Overall Study Withdrawal by Subject	14	6

Baseline Characteristics

Symptom Management After Breast Cancer Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine Patch n=14 Participants Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.	Placebo Patch n=7 Participants Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.	Total n=21 Participants Total of all reporting groups
Age, Continuous	51.2 years STANDARD_DEVIATION 10.3 • n=93 Participants	46.1 years STANDARD_DEVIATION 13.5 • n=4 Participants	49.5 years STANDARD_DEVIATION 11.4 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	7 Participants n=4 Participants	21 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized White	9 participants n=93 Participants	2 participants n=4 Participants	11 participants n=27 Participants
Race/Ethnicity, Customized Black	3 participants n=93 Participants	0 participants n=4 Participants	3 participants n=27 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	1 participants n=93 Participants	3 participants n=4 Participants	4 participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Mixed Ethnic Background	1 participants n=93 Participants	2 participants n=4 Participants	3 participants n=27 Participants
Region of Enrollment United States	14 participants n=93 Participants	7 participants n=4 Participants	21 participants n=27 Participants
Average pain intensity	5.3 units on a scale STANDARD_DEVIATION 2.3 • n=93 Participants	4.2 units on a scale STANDARD_DEVIATION 1.1 • n=4 Participants	4.8 units on a scale STANDARD_DEVIATION 1.9 • n=27 Participants
Worst pain intensity	7.8 units on a scale STANDARD_DEVIATION 1.5 • n=93 Participants	6.4 units on a scale STANDARD_DEVIATION 4.8 • n=4 Participants	7.1 units on a scale STANDARD_DEVIATION 3.3 • n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lidocaine Patch Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.	Placebo Patch n=1 Participants Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks	—	4.0 units on a scale 0.0

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

Adverse Events

Lidocaine Patch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Patch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christine Miaskowski, PI

University of California, San Francisco

Phone: 415-476-9407

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place