A self-controlled clinical trial by Hanai et al investigating the efficacy of cryotherapy for the prevention of chemotherapy-induced peripheral neuropathy in patients with breast cancer treated with paclitaxel has found that cryotherapy resulted in a clinically and statistically significant reduction in patient-reported subjective symptoms, diminished objective signs (tactile and thermosensory), and prevention of manipulative dexterity. These study findings suggest cryotherapy may be an effective strategy in the prevention of neuropathy in patients undergoing paclitaxel treatment. These study findings were published in the Journal of the National Cancer Institute.
The researchers evaluated the preventive effects of cryotherapy for chemotherapy-induced peripheral neuropathy among 40 patients with breast cancer prescribed paclitaxel. The patients were recruited from the Kyoto University Hospital in Japan between May 2014 and August 2015. The patients received weekly treatments of 80 mg/m2 of paclitaxel for 1 hour for at least 12 cycles, for a cumulative dose of 960 mg/m2.
The patients wore frozen gloves and socks on their dominant side for 90 minutes, including the entire duration of drug infusion. The researchers then compared symptoms on the treated sides with those on the untreated sides. The primary endpoint was the incidence of chemotherapy-induced peripheral neuropathy assessed by changes in tactile sensitivity from a pretreatment baseline. The researchers also assessed thermosensory deficits, subjective symptoms as reported in a Patient Neuropathy Questionnaire (PNQ), manipulative dexterity, and the time to events and hazard ratio (HR) by PNQ. All statistical tests were two-sided.
Among the 40 patients, 4 did not reach the cumulative dose (due to the occurrence of pneumonia, severe fatigue, severe liver dysfunction, and macular edema), leaving 36 patients for analysis. None dropped out due to cold intolerance.
The researchers found the incidence of objective and subjective signs of chemotherapy-induced peripheral neuropathy was clinically and statistically significantly lower on the intervention side than on the control side (hand: tactile sensitivity = 27.8% vs 80.6%, odds ratio [OR] = 20.00, 95% confidence interval [CI] = 3.20–828.96, P < .001; foot: tactile sensitivity = 25.0% vs 63.9%, OR = infinite, 95% CI = 3.32 to infinite, P < .001; hand: warm sense = 8.8% vs 32.4%, OR = 9.00, 95% CI = 1.25–394.48, P = .02; foot: warm sense: 33.4% vs 57.6%, OR = 5.00, 95% CI = 1.07–46.93, P = .04; hand: PNQ = 2.8% vs 41.7%, OR = infinite, 95% CI = 3.32 to infinite, P < .001; foot: PNQ = 2.8% vs 36.1%, OR = infinite, 95% CI = 2.78 to infinite, P < .001; hand: hazard ratio [HR] = 0.13, 95% CI = 0.05–0.34; foot: HR = 0.13, 95% CI = 0.04–0.38, dexterity mean delay = –2.5 seconds, standard deviation = 12.0 seconds, vs +8.6 seconds, standard deviation = 25.8 seconds, P = .005).
“We conclude that cryotherapy is a simple, safe, and effective strategy for the prevention of [chemotherapy-induced peripheral neuropathy] in patients with cancer undergoing paclitaxel treatment. Cryotherapy could support the delivery of optimal chemotherapy by preventing a dose delay or reduction, as well as inhibiting the deterioration of quality of life in cancer patients during and after treatment,” concluded the study authors.
Hiroshi Ishiguro, MD, PhD, FACP, of the International Health and Welfare Hospital in Nasushiobara, Tochigi, Japan, is the corresponding author of this study.
Funding for this study was provided by the Japan Society for the Promotion of Science and the Ministry of Education, Culture, Sports, Science, and Technology.
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