Trial Outcomes & Findings for Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery (NCT NCT03794388)
NCT ID: NCT03794388
Last Updated: 2026-05-05
Results Overview
Pain intensity was assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where: * 0 indicates no pain, * 10 indicates the worst imaginable pain. Higher scores represent worse pain. The score was collected at 2 months
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
140 participants
Primary outcome timeframe
2 months
Results posted on
2026-05-05
Participant Flow
Participant milestones
| Measure |
Arm CAPSAICINE Topical
Application of capsaicin patches at 8% on the painful area
1 to 2 patches will be administered during the consultation. If necessary, a second application will be realized 3 months later.
Capsaicin: Application of capsaicin patches at 8% on painful area
|
Arm PREGABALINE
Pregabalin tablets will be initiated at a dose of 50 mg / day taken in 2 doses Depending on the tolerance, the dose will be increased to 100 mg / day and then to 150 mg / day to reach a maximum dose of 600 mg / day.
An interval of 3 to 7 days must be observed between each dose increase.
Pregabalin: Taking Pregabalin tablets
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
65
|
51
|
|
Overall Study
NOT COMPLETED
|
5
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery
Baseline characteristics by cohort
| Measure |
Arm CAPSAICINE Topical
n=65 Participants
Application of capsaicin patches at 8% on the painful area
1 to 2 patches will be administered during the consultation. If necessary, a second application will be realized 3 months later.
Capsaicin: Application of capsaicin patches at 8% on painful area
|
Arm PREGABALINE
n=51 Participants
Pregabalin tablets will be initiated at a dose of 50 mg / day taken in 2 doses Depending on the tolerance, the dose will be increased to 100 mg / day and then to 150 mg / day to reach a maximum dose of 600 mg / day.
An interval of 3 to 7 days must be observed between each dose increase.
Pregabalin: Taking Pregabalin tablets
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=54 Participants
|
39 Participants
n=60 Participants
|
88 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=54 Participants
|
12 Participants
n=60 Participants
|
28 Participants
n=114 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=54 Participants
|
51 Participants
n=60 Participants
|
116 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
65 Participants
n=54 Participants
|
51 Participants
n=60 Participants
|
116 Participants
n=114 Participants
|
|
Region of Enrollment
France
|
65 participants
n=54 Participants
|
51 participants
n=60 Participants
|
116 participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPain intensity was assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where: * 0 indicates no pain, * 10 indicates the worst imaginable pain. Higher scores represent worse pain. The score was collected at 2 months
Outcome measures
| Measure |
Arm CAPSAICINE Topical
n=65 Participants
Application of capsaicin patches at 8% on the painful area
1 to 2 patches will be administered during the consultation. If necessary, a second application will be realized 3 months later.
Capsaicin: Application of capsaicin patches at 8% on painful area
|
Arm PREGABALINE
n=51 Participants
Pregabalin tablets will be initiated at a dose of 50 mg / day taken in 2 doses Depending on the tolerance, the dose will be increased to 100 mg / day and then to 150 mg / day to reach a maximum dose of 600 mg / day.
An interval of 3 to 7 days must be observed between each dose increase.
Pregabalin: Taking Pregabalin tablets
|
|---|---|---|
|
Change in Neuropathic Pain Score at 2 Months (Numeric Rating Scale 0-10)
|
4.1 units on a scale
Standard Deviation 2.5
|
4.6 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 6 monthsNeuropathic pain intensity was assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The outcome measure represents the change in NRS score from baseline to 6 months, calculated as the score at 6 months minus the score at baseline. Negative values indicate an improvement in pain, and positive values indicate worsening of pain.
Outcome measures
| Measure |
Arm CAPSAICINE Topical
n=65 Participants
Application of capsaicin patches at 8% on the painful area
1 to 2 patches will be administered during the consultation. If necessary, a second application will be realized 3 months later.
Capsaicin: Application of capsaicin patches at 8% on painful area
|
Arm PREGABALINE
n=51 Participants
Pregabalin tablets will be initiated at a dose of 50 mg / day taken in 2 doses Depending on the tolerance, the dose will be increased to 100 mg / day and then to 150 mg / day to reach a maximum dose of 600 mg / day.
An interval of 3 to 7 days must be observed between each dose increase.
Pregabalin: Taking Pregabalin tablets
|
|---|---|---|
|
Change From Baseline to 6 Months in Neuropathic Pain Score (Numeric Rating Scale 0-10)
|
-2.2 units
Standard Deviation 2.5
|
-2.7 units
Standard Deviation 2.9
|
Adverse Events
Arm CAPSAICINE Topical
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm PREGABALINE
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm CAPSAICINE Topical
n=65 participants at risk
Application of capsaicin patches at 8% on the painful area
1 to 2 patches will be administered during the consultation. If necessary, a second application will be realized 3 months later.
Capsaicin: Application of capsaicin patches at 8% on painful area
|
Arm PREGABALINE
n=51 participants at risk
Pregabalin tablets will be initiated at a dose of 50 mg / day taken in 2 doses Depending on the tolerance, the dose will be increased to 100 mg / day and then to 150 mg / day to reach a maximum dose of 600 mg / day.
An interval of 3 to 7 days must be observed between each dose increase.
Pregabalin: Taking Pregabalin tablets
|
|---|---|---|
|
Injury, poisoning and procedural complications
Application site burning
|
12.3%
8/65 • Number of events 8 • 6 months
|
7.8%
4/51 • Number of events 4 • 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/65 • 6 months
|
9.8%
5/51 • Number of events 5 • 6 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/65 • 6 months
|
9.8%
5/51 • Number of events 5 • 6 months
|
|
Nervous system disorders
Vertigo
|
0.00%
0/65 • 6 months
|
15.7%
8/51 • Number of events 8 • 6 months
|
|
Nervous system disorders
Confusion
|
0.00%
0/65 • 6 months
|
7.8%
4/51 • Number of events 4 • 6 months
|
|
Nervous system disorders
Insomnia
|
0.00%
0/65 • 6 months
|
5.9%
3/51 • Number of events 3 • 6 months
|
Additional Information
Dr DENIS DUPOIRON
INSTITUT DE CANCEROLOGIE DE L'OUEST
Phone: 02 41 35 27 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place