Impact of Cryotherapy on Sensory, Motor, and Autonomic Neuropathy in Breast Cancer Patients Receiving Paclitaxel: A Randomized, Controlled Trial.

Autor:	Ng DQ; Department of Pharmacy, National University of Singapore, Singapore, Singapore.; Department of Clinical Pharmacy Practice, University of California, Irvine, Irvine, CA, United States., Tan CJ; Department of Pharmacy, National University of Singapore, Singapore, Singapore., Soh BC; Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore., Tan MML; Division of Nursing, National Cancer Centre Singapore, Singapore, Singapore., Loh SY; Division of Nursing, National Cancer Centre Singapore, Singapore, Singapore., Tan YE; Department of Neurology, Singapore General Hospital, Singapore, Singapore., Ong HH; Department of Neurology, Singapore General Hospital, Singapore, Singapore., Teng PPC; Department of Neurology, Singapore General Hospital, Singapore, Singapore., Chan JJ; Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore., Chay WY; Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore., Lee J; Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore., Lai G; Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore., Beh SY; Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore., Tan TJY; Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore., Yap YS; Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore., Lee GE; Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore., Wong M; Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore., Dent R; Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.; Duke-NUS Medical School, Singapore, Singapore., Lo YL; Department of Neurology, Singapore General Hospital, Singapore, Singapore.; Duke-NUS Medical School, Singapore, Singapore.; National Neuroscience Institute, Singapore, Singapore., Chan A; Department of Clinical Pharmacy Practice, University of California, Irvine, Irvine, CA, United States.; Duke-NUS Medical School, Singapore, Singapore.; Department of Pharmacy, National Cancer Centre Singapore, Singapore, Singapore., Loh KW; Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.; Duke-NUS Medical School, Singapore, Singapore.
Jazyk:	angličtina
Zdroj:	Frontiers in neurology [Front Neurol] 2020 Dec 18; Vol. 11, pp. 604688. Date of Electronic Publication: 2020 Dec 18 (Print Publication: 2020).
DOI:	10.3389/fneur.2020.604688
Abstrakt:	Introduction: We conducted a randomized controlled trial evaluating the efficacy and tolerability of cryotherapy in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with early breast cancer receiving neo/adjuvant weekly paclitaxel. Methods: Patients were recruited from the National Cancer Centre Singapore and randomized (1:1) to receive either cryotherapy or usual care. Cryotherapy was applied as frozen gloves and socks on all extremities from 15 min before paclitaxel until 15 min post-infusion every cycle. Efficacy was measured by patient-reported outcomes (Patient Neurotoxicity Questionnaire [PNQ] and EORTC QLQ-CIPN20) and electrophysiological assessments. The primary endpoint was PNQ severity at 2 weeks after 12 cycles of weekly paclitaxel. Results: A total of 46 patients were recruited, of which 8 dropped out before paclitaxel treatment, leaving 38 evaluable. There was no significant difference in PNQ severity between cryotherapy and usual care at 2 weeks after paclitaxel treatment (sensory: p = 0.721; motor: p = 1.000). A benefit was observed at 3 months post-paclitaxel based on PNQ (sensory: 14.3 vs. 41.2%, p = 0.078; motor: 0 vs. 29.4%, p = 0.012) and CIPN20 (sensory: β = -3.6, 95%CI = -10.5-3.4, p = 0.308; motor: β = -7.3, 95%CI = -14.6-0, p = 0.051). Additionally, cryotherapy subjects have lower CIPN20 autonomic score (β = -5.84, 95%CI = -11.15 to -0.524, p = 0.031) and higher sympathetic skin response hand amplitudes (β = 0.544, 95%CI = 0.108-0.98, p = 0.014), suggesting possible autonomic benefits from cryotherapy. Temporary interruption with cryotherapy occurred in 80.9% of the subjects due to cold intolerance. Conclusions: There is insufficient evidence that cryotherapy prevents sensory neuropathy which may be due to the high rates of cryotherapy interruption in this study. The autonomic benefits of cryotherapy should be further investigated with appropriate outcome measures. Clinical Trial Registration: ClinicalTrials.gov: NCT03429972. Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2020 Ng, Tan, Soh, Tan, Loh, Tan, Ong, Teng, Chan, Chay, Lee, Lai, Beh, Tan, Yap, Lee, Wong, Dent, Lo, Chan and Loh.)
Databáze:	MEDLINE
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