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Published on: October 27, 2014
Efficacy of Cryotherapy in Preventing Taxane-Induced Neuropathy: The CryoPac Randomised Controlled Trial
M E Lendorf1, M B Bille2, S M Krog3
1Department of Oncology and Palliative Medicine, North Zealand Hospital, University of Copenhagen, Denmark; Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Denmark.
Background:
Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a common and debilitating adverse effect of taxane chemotherapy. Currently there is no established strategy for prevention or treatment. Smaller studies have suggested that cryotherapy may prevent CIPN.
Design:
We conducted a randomized controlled trial comparing usual care with cryotherapy using frozen gloves and socks during each taxane treatment. Participants were stratified by site and chemotherapy regiment and randomized 1:1 to cryotherapy or usual care. Eligible patients had a performance status of 0-1. Exclusion criteria included previous taxane chemotherapy, symptoms of CIPN, and a baseline Total Neuropathy Score (TNS) > 0. The primary endpoint was CIPN incidence at the End of Treatment (EoT) defined as TNS ≥2. Secondary endpoints included peripheral neuropathy evaluated with NCI-CTCAE v5.0, patient-reported outcomes using EORTC QLQ-CIPN20 and QLQ-C30, and quantitative sensory testing (QST).
Results:
A total of 268 patients were randomised; 51 dropped out, leaving 217 for analysis (cryotherapy 123, usual care 94 patients). CIPN incidence at EoT was 78% overall and did not differ significantly between the groups (cryotherapy: 91/123 [74%], 95% CI 0.65 to 0.81; control: 79/94 [84%], 95% CI 0.75 to 0.90; P= .071). Analysis of EORTC QLQ-CIPN20 subscales showed that the cryotherapy group had reduced tingling in hands (P=.025), numbness in hands (P=.025) and feet (p=0.0005), and less trouble manipulating small objects (P=.006). No difference was found in CTCAE grade ≥ 2 CIPN between groups (P = .2). QST showed that cryotherapy reduced tactile disturbance on the monofilament test (P=.006). No difference was observed in QLQ-C30 scores. Cryotherapy did not influence dose modifications. Compliance with cryotherapy was 67%.
Conclusions:
Cryotherapy did not significantly reduce CIPN incidence (TNS ≥2) at EoT, but cryotherapy treated patients reported fewer sensory symptoms and demonstrated reduced tactile disturbance. Longer follow-up may reveal benefits of cryotherapy for persistent CIPN, supporting possible clinical relevance.
Clinical Trial Registration:
ClinicalTrials.gov: NCT05928429.