Cryotherapy for the prevention of weekly paclitaxel-induced peripheral adverse events in breast cancer patients

Abstract

Purpose This randomized phase II study was conducted to investigate the efficacy of cryotherapy in preventing peripheral neuropathy and dermatological adverse events in breast cancer patients treated with weekly paclitaxel. Methods Patients treated with 12 weekly doses of paclitaxel for breast cancer were randomized (1:1) into a cryotherapy or control group. The primary endpoint was the percentage of patients with a marked decrease in the Functional Assessment of Cancer Therapy-Neurotoxicity (FACT-NTX) score. The secondary endpoints were Patient Neurotoxicity Questionnaire (PNQ), Common Terminology Criteria for Adverse Event (CTCAE) for peripheral neuropathy, and FACT-Taxane score. Results Forty-four patients were randomly assigned to the cryotherapy (n = 22) or control groups (n = 22). The percentage of patients with a marked decrease in FACT-NTX scores was significantly lower in the cryotherapy group than in the control group (41 vs. 73%, p = 0.03). The incidence of CTCAE grade ≥ 2 sensory (p = 0.001) and motor peripheral neuropathy (p = 0.01), and PNQ grade D or higher for sensory peripheral neuropathy (p = 0.02), and decrease in the FACT-Taxane score (p = 0.02) were also significantly lower in the cryotherapy group than in the control group. There were no serious side effects associated with cryotherapy. Conclusion Cryotherapy is an effective approach for prevention of peripheral neuropathy and dermatological adverse events in breast cancer patients treated with weekly paclitaxel.

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

“…Firstly, by permitting periods of temporary cryotherapy interruption for intolerant patients, all subjects in our study had removed their devices at least once regardless of reasons. In comparison, the Japanese study reported that 68% of their patients were able to wear the hypothermia gloves and socks without interruption, and further analysis revealed greater cryotherapy benefits among these patients (20). This suggests that the continuous application of cryotherapy may be critical to produce a sustained benefit in preventing CIPN.…”

“…Existing randomized controlled trials that utilized the same Elasto-Gel TM hypothermia devices reported potential reduction in neuropathic symptoms with cryotherapy (19,20). Less sensory and motor symptoms with cryotherapy was observed in one Japanese study (20), and less neuropathic symptoms leading to improved quality of life was observed in another study (19).…”

“…The first evidence came as an explorative analysis, revealing that patients utilizing frozen gloves and socks for the prevention of docetaxel-induced nail toxicity experienced a 44% reduction in the risk of CIPN (13). Other studies have examined if similar benefits can be observed among patients receiving chemotherapy (14)(15)(16)(17)(18)(19)(20). However, the findings of these studies have been inconsistent, exemplifying the need for more confirmatory studies (21).…”

Cryotherapy for the prevention of chemotherapy-induced peripheral neuropathy: A systematic review

“…17–24 Additionally, exposure to cryotherapy treatment ranged from 90 minutes to 210 minutes and some studies required changing insulators every 45-60 minutes. 16–26 In addition to frozen gloves and socks, cryotherapy was also assessed using continuous limb cooling, application of crushed ice, and simultaneous compression and cryotherapy. 16 , 25 , 26 Differences in cryotherapy administration methods make it challenging to determine which is the most safe and efficacious, reinforcing the need for better designed, larger trials that utilize consistent cryotherapy techniques to identify the most effective and well tolerated method of cryotherapy.…”

“…A total of 11 studies were included in the final review (Table 1). [16][17][18][19][20][21][22][23][24][25][26] Literature review The average age of patients in the cryotherapy group was 53. At the end of 12 weeks, there was no difference in the AUC of the CIPN-20 scores between the two groups.…”