Baseline characteristics of a phase III randomized controlled trial of acupuncture for chemotherapy-induced peripheral neuropathy (ACT trial).

Abstract

e24173 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common, painful, and disabling chemotherapy toxicity with limited effective treatments. The ACT trial is a two-arm, parallel, randomized controlled trial comparing electroacupuncture (EA) with sham acupuncture (SA) for CIPN pain management. Methods: Eligible participants were English-proficient adults (≥18 years) with no evidence of disease or stable disease who had completed neurotoxic chemotherapy ≥3 months prior and reported persistent moderate-to-severe CIPN pain (average pain score ≥4 on Brief Pain Inventory–Short Form [BPI-SF] and grade ≥1 sensory pain per CTCAE v5.0). Participants maintained stable pain medication regimens and avoided new medications during the initial 12 weeks.Those with pacemakers or electronically charged medical devices were excluded. Descriptive statistics summarized baseline characteristics. Results: A total of 255 participants enrolled across Memorial Sloan Kettering Cancer Center (70.6%) and Dana-Farber Cancer Institute (29.4%). Mean age was 60.6 years (SD 11.9); 77.3% were female. The participants were racially and ethnically diverse, including 64.7% White, 15.7% Black, 7.8% Asian, and 9.7% Hispanic participants. Mean BMI was 28.47 (SD 6.10). Prior cancer diagnoses included breast (43.1%), colorectal (16.9%), and ovarian (9.0%) cancers. Cancer stage at diagnosis was Stage I (25.7%), Stage II (28.7%), Stage III (31.6%), and Stage IV (13.5%). Baseline symptom burden was notable, with mean score of 5.18 (SD 1.84) for BPI average pain, 6.16 (SD 1.96) for BPI worst pain, 45.18 (SD 16.37) for the Neuropathy Pain Scale (NPS), and 23.61 (SD 8.25) for the Functional Assessment of Cancer Therapy–Gynecologic Oncology Group–Neurotoxicity (FACT-GOG-NTX). Conclusions: ACT trial participants represented a diverse patient population and reported clinically meaningful, moderate-to-severe neuropathic pain following neurotoxic chemotherapy. This highlights substantial unmet symptom management needs and supports evaluation of electroacupuncture as a non-pharmacologic CIPN intervention. Outcome analyses will be reported subsequently. Clinical trial information: NCT04917796 . Baseline characteristics of ACT trial participants. Study site MSK 180 (70.6%), DFCI 75 (29.4%) Age, mean (SD), years 60.6 (11.9) Female, n (%) 184 (77.3%) White, n (%) 165 (64.7%) Hispanic, n (%) 23 (9.7%) BMI, mean (SD) 28.47 (6.10) BPI worst pain, mean (SD) 6.16 (1.96) BPI average pain, mean (SD) 5.18 (1.84) NPS, mean (SD) 45.18 (16.37) FACT-GOG-NTX, mean (SD) 23.61 (8.25) Abbreviations: MSK, Memorial Sloan Kettering Cancer Center; DFCI, Dana-Farber Cancer Institute; SD, standard deviation; BMI, body mass index; BPI, Brief Pain Inventory; NPS, Neuropathy Pain Scale; FACT-GOG-NTX, Functional Assessment of Cancer Therapy–Gynecologic Oncology Group–Neurotoxicity subscale.