High-Concentration Capsaicin Patch and Oral Pregabalin as Second-Line Therapy for Intercostobrachial Neuralgia After Breast Cancer Surgery: Open-Label Follow-Up of a Multicenter Randomized Controlled Clinical Trial.
The CAPTRANE trial evaluated the efficacy of randomly assigned high-concentration capsaicin patch (HCCP) versus daily oral pregabalin (PGB) in adults with chronic neuropathic pain (DN4 ≥ 4) post-breast cancer surgery. The objective of its 4-month open-label extension following patient's self-selection of their second treatment (HCCP, PGB, or none) was to explore efficacy and safety of various strategies.
The study was conducted in France between March 2019 and November 2022. At each clinic visit, we assessed pain intensity (NRS, 0-10), painful area (cm2), mood (HADS), and quality of life (EQ-5D-5L). Standard statistical tests were used.
Data from 116 patients (all females; 76% aged < 65 years) were collected. At Month 2, 71% (46/65) of HCCP-treated patients received a second HCCP application and none switched to PGB, whereas 27% (14/51) continued on PGB and 49% (25/51) of PGB-treated patients switched to HCCP. At Month 6, NRS scores had decreased in HCCP-treated patients, including PGB/HCCP-treated patients, with a reduction of -2.0 [-4.0; 0.0] and -3.0 [-4.0; -2.0] in the HCCP/HCCP and PGB/HCCP group, respectively (median[interquartile]). Adverse events aligned with those expected with HCCP and PGB; none were serious.
This first study to examine switching between PGB and HCCP treatments for chronic intercostobrachial neuropathic pain after breast cancer surgery showed patients' preference for HCCP, confirmed the benefit of repeated HCCP applications, and indicated that HCCP could be preceded by PGB without compromising efficacy or safety. These findings suggest that HCCP may be used early in this population, and PGB initiated before HCCP to relieve patients waiting for HCCP application.
The study was conducted in France between March 2019 and November 2022. At each clinic visit, we assessed pain intensity (NRS, 0-10), painful area (cm2), mood (HADS), and quality of life (EQ-5D-5L). Standard statistical tests were used.
Data from 116 patients (all females; 76% aged < 65 years) were collected. At Month 2, 71% (46/65) of HCCP-treated patients received a second HCCP application and none switched to PGB, whereas 27% (14/51) continued on PGB and 49% (25/51) of PGB-treated patients switched to HCCP. At Month 6, NRS scores had decreased in HCCP-treated patients, including PGB/HCCP-treated patients, with a reduction of -2.0 [-4.0; 0.0] and -3.0 [-4.0; -2.0] in the HCCP/HCCP and PGB/HCCP group, respectively (median[interquartile]). Adverse events aligned with those expected with HCCP and PGB; none were serious.
This first study to examine switching between PGB and HCCP treatments for chronic intercostobrachial neuropathic pain after breast cancer surgery showed patients' preference for HCCP, confirmed the benefit of repeated HCCP applications, and indicated that HCCP could be preceded by PGB without compromising efficacy or safety. These findings suggest that HCCP may be used early in this population, and PGB initiated before HCCP to relieve patients waiting for HCCP application.
Authors
Dupoiron Dupoiron, Bienfait Bienfait, Seegers Seegers, Jubier-Hamon Jubier-Hamon
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