Phase 1-2 study of limb cryocompression to prevent taxane-based chemotherapy-induced peripheral neuropathy

Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting toxicity of taxane-based chemotherapy with no established preventive strategy. A phase 1-2 study at three centers in Singapore evaluated a novel limb cryocompression device for reducing CIPN in patients with cancer receiving taxane-based chemotherapy. Patients received limb cryocompression (11⁰C; cyclic compression 5-15 mm Hg) starting 30 minutes before, during, and 30 minutes after taxane infusion. Primary endpoints included safety, tolerability, and clinically significant CIPN assessed by physician-graded CTCAE and patient-reported EORTC QLQ-CIPN20. A ≥ 3-point increase in the EORTC QLQ-CIPN20 sensory subscale defined clinically significant patient-reported CIPN. A total of 150 patients were enrolled (median age 52 years; 96.6% female; 89.0% breast cancer). Taxane regimens included paclitaxel (71.2%, docetaxel (28.1%), and nab-paclitaxel (0.68%); 44.5% received concurrent scalp cooling. Among 146 evaluable patients, 123 (84.2%) completed all cryocompression cycles. Fifteen patients (10.3%) withdrew because of cold intolerance. At treatment completion, 22.8% had CTCAE G1 CIPN and 1.6% had G2 CIPN; none developed G3-G4 CIPN. Clinically significant patient-reported sensory CIPN occurred in 13.9% at 12 weeks and 13.1% at 24 weeks; 5.7% required taxane dose modification because of CIPN. The authors conclude that limb cryocompression is safe, well-tolerated, and associated with low rates of clinically significant CIPN in patients receiving taxane-based chemotherapy. A multicenter randomized controlled trial is ongoing to validate these findings (SWOG S2205 ICE COMPRESS).