Elsevier

Annals of Oncology

Volume 31, Issue 1, January 2020, Pages 131-136
Annals of Oncology

Original Article
Multicenter randomized controlled trial to evaluate the efficacy and tolerability of frozen gloves for the prevention of chemotherapy-induced peripheral neuropathy

https://doi.org/10.1016/j.annonc.2019.09.006Get rights and content
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Highlights

  • CIPN is a common side-effect of taxanes and oxaliplatin.

  • No improvement in CIPN-subscales was reported in patients wearing frozen gloves.

  • FGs reduce some neuropathy symptoms in hands potentially resulting in a better QOL.

Background

This study investigated the efficacy and tolerability of wearing frozen gloves (FGs) during chemotherapy to prevent chemotherapy-induced peripheral neuropathy (CIPN) as reported by patients and influence on quality of life (QoL).

Patients and methods

Cancer patients starting treatment with oxaliplatin, docetaxel or paclitaxel between February 2013 and May 2016 at the medical oncology department were eligible. Patients were randomized into groups wearing FGs on both hands during treatment and those not wearing FGs during treatment. Self-reported CIPN and QoL were measured with the European Organisation for the Research and Treatment of Cancer Quality of Life (EORTC QLQ) CIPN20 and QLQ-C30 at four time points: baseline (t0), after three cycles (t1), end of chemotherapy (t2) and after 6 months (t3).

Results

The study included 180 patients with 90 patients in both arms. They mostly underwent treatment of colorectal or breast cancer. Thirty-one patients (34%) discontinued FGs, mainly due to discomfort. Intention-to-treat analyses showed no important differences in reported EORTC QLQ CIPN20 subscales between the FG group and control group; however, the analyses showed the patients experienced reduced tingling in fingers/hands [β = −10.20, 95% confidence interval (CI) = −3.94 to −3.14, P = 0.005] and less trouble opening a jar or bottle due to loss of strength in hands (β = −6.97, 95% CI = −13.53 to −0.40, P = 0.04) in the FG group compared with the control group. Per-protocol analyses showed similar results: reduced aching or burning pain in fingers/hands (β = −4.37, 95% CI = −7.90 to −0.83, P = 0.02) and cramps in hands (β = −3.76, 95% CI = −7.38 to −0.14, P = 0.04). Differences in tingling in fingers/hands at t1 were clinically relevant. In addition, those treated with FGs reported overall better QoL (β = 4.79, 95% CI = 0.37 to 9.22, P = 0.03) and physical functioning (β = 5.66, 95% CI = 1.59 to 9.73, P = 0.007) than the control. No difference in dose reductions was observed.

Conclusions

No difference in CIPN subscales was reported between intervention arms. Wearing FGs might reduce some neuropathy symptoms in the hands, potentially resulting in a better QoL; however, one-third of the FG group discontinued the study before the end of treatment. Future studies should focus on the method of limb hypothermia to prevent CIPN.

Trial registration number

NL39650.015.12.

Key words

chemotherapy-induced neuropathy
frozen gloves
neuropathy
prevention
quality of life
supportive care

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Note: The findings of this manuscript have partly been presented at a poster discussion session at the ESMO conference of 2017 (abstract nr 1549_PD).