Trial Outcomes & Findings for Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction (NCT NCT01591746)

Results Overview

The numeric pain intensity scale (NPIS) will be completed at the preoperative visit and again at the first postoperative visit. The NPIS is a visual analog scale (VAS) commonly used to assess clinical pain. Subjects are asked to rate their pain on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

131 participants

Primary outcome timeframe

preoperative visit, first postoperative visit (1-2 weeks post surgery)

Results posted on

2019-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Group A - Botulinum Toxin Type A 100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast Botulinum Toxin Type A	Group B - Placebo 5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A
Overall Study STARTED	68	63
Overall Study COMPLETED	68	63
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A - Botulinum Toxin Type A n=68 Participants 100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast Botulinum Toxin Type A	Group B - Placebo n=63 Participants 5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A	Total n=131 Participants Total of all reporting groups
Age, Continuous	49.9 years STANDARD_DEVIATION 11.1 • n=68 Participants	48.4 years STANDARD_DEVIATION 11.5 • n=63 Participants	49.1 years STANDARD_DEVIATION 11.3 • n=131 Participants
Sex: Female, Male Female	68 Participants n=68 Participants	63 Participants n=63 Participants	131 Participants n=131 Participants
Sex: Female, Male Male	0 Participants n=68 Participants	0 Participants n=63 Participants	0 Participants n=131 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	68 participants n=68 Participants	63 participants n=63 Participants	131 participants n=131 Participants
Body Mass Index (BMI)	27.6 kg/m^2 STANDARD_DEVIATION 5.9 • n=68 Participants	26.6 kg/m^2 STANDARD_DEVIATION 8.1 • n=63 Participants	27.1 kg/m^2 STANDARD_DEVIATION 7 • n=131 Participants

PRIMARY outcome

Timeframe: preoperative visit, first postoperative visit (1-2 weeks post surgery)

The numeric pain intensity scale (NPIS) will be completed at the preoperative visit and again at the first postoperative visit. The NPIS is a visual analog scale (VAS) commonly used to assess clinical pain. Subjects are asked to rate their pain on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Outcome measures
Measure	Group A - Botulinum Toxin Type A n=68 Participants 100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast Botulinum Toxin Type A	Group B - Placebo n=63 Participants 5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A
Change From Baseline in Average Pain Scores Using a Numeric Pain Intensity Scale	2 score on a scale Interval 1.5 to 4.0	3 score on a scale Interval 2.0 to 4.0

PRIMARY outcome

Timeframe: first post-operative visit (1-2 weeks post surgery)

The Physical Well-Being scale of the BREAST-Q, Reconstruction module, will be used for this purpose. The BREAST-Q is a validated patient-reported outcome measure to accurately assess quality of life and patient satisfaction. The Reconstruction module Physical Well-Being scale has questions on the function and participation in activities before and after breast reconstruction. For this study, subjects were asked to answer 16 questions on how often they experienced each symptom, using score of 1 to 5, where 1 was none of the time and 5 was very often. Answers from these questions were combined to provide a total physical well-being score (for a total possible range of 16-80) for each patient at each visit. Lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction.

Outcome measures

Outcome measures
Measure	Group A - Botulinum Toxin Type A n=68 Participants 100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast Botulinum Toxin Type A	Group B - Placebo n=63 Participants 5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A
Physical Well-Being Using the BREAST-Q, Reconstruction Module	63 score on a scale Interval 57.0 to 68.0	60 score on a scale Interval 57.0 to 68.0

SECONDARY outcome

Timeframe: Single intra-operative measurement at first surgery

Population: Volume measurements were not captured for all subjects.

The amount of initial intraoperative fill volume in milliliters (mL) in the tissue expander at the time of surgery divided by the manufacturers recommended total tissue expander volume will be measured. Each breast will be measured separately.

Outcome measures

Outcome measures
Measure	Group A - Botulinum Toxin Type A n=60 Participants 100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast Botulinum Toxin Type A	Group B - Placebo n=60 Participants 5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A
Initial Intraoperative Fill Volume in Milliliters (mL) Right breast	63.5 mL Standard Deviation 23.0	60.4 mL Standard Deviation 20.0
Initial Intraoperative Fill Volume in Milliliters (mL) Left breast	60.1 mL Standard Deviation 23.1	60.0 mL Standard Deviation 21.1

SECONDARY outcome

Timeframe: up to 24 weeks post-operatively

The total number of tissue expansion visits completed post-operatively.

Outcome measures

Outcome measures
Measure	Group A - Botulinum Toxin Type A n=66 Participants 100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast Botulinum Toxin Type A	Group B - Placebo n=62 Participants 5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A
Number of Tissue Expansion Visits	3 visits Interval 2.0 to 4.0	3 visits Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: Up to 24 weeks post-operatively

Population: Volume measurement were not captured on all subjects.

Measurement of total expansion volume in milliliters (mL).

Outcome measures

Outcome measures
Measure	Group A - Botulinum Toxin Type A n=61 Participants 100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast Botulinum Toxin Type A	Group B - Placebo n=59 Participants 5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A
Total Volume of Tissue Expansion	80 mL Interval 63.0 to 104.0	75 mL Interval 56.0 to 100.0

SECONDARY outcome

Timeframe: 6 months after first surgery

The rate of reconstruction failure will be measured by the number of subjects who have tissue expander removal.

Outcome measures

Outcome measures
Measure	Group A - Botulinum Toxin Type A n=68 Participants 100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast Botulinum Toxin Type A	Group B - Placebo n=63 Participants 5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A
Rate of Reconstruction Failure	1 Participants	0 Participants

Adverse Events

Group A - Botulinum Toxin Type A

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Group B - Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group A - Botulinum Toxin Type A n=68 participants at risk 100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast Botulinum Toxin Type A	Group B - Placebo n=63 participants at risk 5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A
Infections and infestations Surgical site infection	1.5% 1/68 • Number of events 1 • Adverse events were collected from baseline until four months postoperatively for each subject, a total average of five years.	3.2% 2/63 • Number of events 2 • Adverse events were collected from baseline until four months postoperatively for each subject, a total average of five years.
Skin and subcutaneous tissue disorders Hematoma requiring reoperation	1.5% 1/68 • Number of events 1 • Adverse events were collected from baseline until four months postoperatively for each subject, a total average of five years.	3.2% 2/63 • Number of events 2 • Adverse events were collected from baseline until four months postoperatively for each subject, a total average of five years.
Blood and lymphatic system disorders Seroma	0.00% 0/68 • Adverse events were collected from baseline until four months postoperatively for each subject, a total average of five years.	6.3% 4/63 • Number of events 4 • Adverse events were collected from baseline until four months postoperatively for each subject, a total average of five years.
Skin and subcutaneous tissue disorders Mastectomy skin flap necrosis	1.5% 1/68 • Number of events 1 • Adverse events were collected from baseline until four months postoperatively for each subject, a total average of five years.	0.00% 0/63 • Adverse events were collected from baseline until four months postoperatively for each subject, a total average of five years.
Skin and subcutaneous tissue disorders Delayed wound healing	7.4% 5/68 • Number of events 5 • Adverse events were collected from baseline until four months postoperatively for each subject, a total average of five years.	3.2% 2/63 • Number of events 2 • Adverse events were collected from baseline until four months postoperatively for each subject, a total average of five years.
Surgical and medical procedures Unplanned reoperation	10.3% 7/68 • Number of events 7 • Adverse events were collected from baseline until four months postoperatively for each subject, a total average of five years.	6.3% 4/63 • Number of events 4 • Adverse events were collected from baseline until four months postoperatively for each subject, a total average of five years.

Additional Information

Dr. Valerie Lemaine, MD, MPH

Mayo Clinic

Phone: 507-284-2736

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place