Single-Arm Combined Phase I/II Study Evaluating Limb Cryocompression to Prevent Chemotherapy-Induced Peripheral Neuropathy in Patients Receiving Taxane-Based Chemotherapy
Rachel S.J. Wong, Aishwarya Bandla, Yang En Yee, Wei Yen Ng, Yi Lin Chen, Yi Qing Tey, Jonathan Binder, Gayathri Kopattil, Samuel Guan Wei Ow, Lee Xin Wei Matilda, Siew Eng Lim, Seri Sastika, Yee Mei Lee, Pei Ling Foo, Haryani Mustadi, Rosadhel Y.H. Goh, Wee Wee Ang, Doreen C.C. Tan, Patrick Burke, Alexandra Sheldrake, Richard Paxman, Su Pin Choo, John Chia, Soo Chin Lee, Joline S.J. Lim, Raghav SundarPurpose
Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting toxicity of taxane-based chemotherapy with no established preventive strategy. We evaluated the safety, tolerability, and efficacy of a novel limb cryocompression device in reducing CIPN.
Methods
In this prospective single-arm phase I/II study conducted at three sites in Singapore, patients with cancer scheduled for taxane-based chemotherapy received limb cryocompression (11°C; cyclic compression 5-15 mm Hg), starting 30 minutes before, during, and 30 minutes after taxane infusion. Primary end points included safety, tolerability, and clinically significant CIPN. CIPN was assessed by physician-graded Common Terminology Criteria for Adverse Events (CTCAE) and the patient-reported European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN 20-item scale (EORTC QLQ-CIPN20). A ≥3-point increase in the EORTC QLQ-CIPN20 sensory subscale defined clinically significant patient-reported CIPN. Taxane dose modifications attributable to CIPN were recorded.
Results
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. A total of 146 patients were evaluable as four patients withdrew before commencing cryocompression. Tolerability was 84.2%; 123 patients completed all cryocompression cycles without premature termination. 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 G3/4 CIPN. Clinically significant patient-reported sensory CIPN occurred in 13.9% at 12 weeks and 13.1% at 24 weeks, and 5.7% required taxane dose modification because of CIPN.
Conclusion
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; ClinicalTrials.gov identifier: