Acupuncture for peripheral neuropathy induced by paclitaxel in early-stage breast cancer: a randomized, parallel, controlled, blinded study in a Brazilian Oncologic Center (PACLILIN Study).

purposeChemotherapy-induced peripheral neuropathy (CIPN) is a common adverse event without effective treatment, just recommended dose reduction, interruption, or modification of the chemotherapy regimen. We conducted a randomized controlled study to evaluate the therapeutic effects of acupuncture.

methodsSixty patients with stage I, II, and III breast cancer who developed CIPN due to neoadjuvant or adjuvant paclitaxel were randomized 1:1 to receive true vs sham acupuncture once per week for 8 weeks. The primary outcome was the response to Neuropathic Pain Symptom Inventory (NPSI), and the secondary outcomes were Visual Analog Scale (VAS) and Functional Assessment of Cancer Therapy-Taxane Version 4 (FACT-taxane) quality of life scale. The questionnaires were administered during weeks 1, 4, 6, and 8 (in person) and week 12 (by telephone).

resultsFor the primary outcome, there were statistically significant differences at week 8 favoring the true acupuncture group for the subscales pressure pain (mean 0.11 vs 0.33; p = 0.01), paroxysmal pain (mean 0.13 vs 0.30; p = 0.037), paresthesia/dysesthesia (mean 0.21 vs 0.43; p = 0.007) and the total score (mean 0.14 vs 0.33; p = 0.02). Regarding secondary outcomes on the VAS scale, there was statistically significant difference favoring the true acupuncture group at visit 8 (mean 3.0 vs 6.0; p = 0.001), but without differences in FACT-taxane, either total score or subscales. There were no differences in any of the outcomes at week 12.

conclusionCIPN-related symptoms in patients with breast cancer who received paclitaxel were reduced by true acupuncture compared with sham acupuncture in the eighth week (ClinicalTrials.gov ID NCT04461977).