Patients were evaluated before each of the 12 cycles of chemotherapy. The incidence of objectively assessed CIPN was significantly reduced from 81% to 28% in hands and 64% to 25% in feet. Incidence of patient-reported CIPN symptoms was also lower in hands (58% at baseline vs 8%) and feet (67% vs 19%).
Further, thermal threshold to hot was reduced significantly in both hands and feet, and though a reduction in thermal threshold to cold was also observed, the data were not statistically significant. In addition to the small study size, Ishiguro said limitations of the study were lack of blinding and randomization. Further, patients were not followed long-term after chemotherapy.
Despite these limitations, Ishiguro said he believes frozen gloves and socks are ready for standard use.
“This easy and safe strategy will be clinically applicable and improve the quality of life of cancer patients undergoing chemotherapy,” the research team noted in their poster.
Ishiguro said the gloves and socks cost about $80 each—he gets them at a discounted price—and that each patient uses 4 gloves and 4 socks. Though this adds up to $640 per patient, Ishiguro pointed out that the gloves and socks are reusable and called the method “very cost-effective.”
On their poster, Ishiguro and colleagues reviewed other methods of cryotherapy that have been previously studied and shown benefit: ice chips in the mouth to reduce fluorouracil-induced mucositis, scalp cooling to reduce hair loss caused by chemotherapy, and cold packs over the eyes to reduce 5-FU-induced ocular toxicity.
Notably, the DigniCap cooling cap system received FDA clearance in December 2015 for marketing in the United States for use in patients with breast cancer who are receiving chemotherapy.
One concern with the DigniCap system was that the cooled scalp would not absorb chemotherapy and would be susceptible to metastases. When asked if chemotherapy absorption was a concern with the frozen gloves and socks, Ishiguro said metastasis in hands and feet is extremely rare and that he has not seen it occur in his practice.
Additional questions do remain, according to Ishiguro.
“The only thing we couldn’t find out is who will get the neuropathy” despite using the frozen socks and gloves, Ishiguro said. “We don’t have data yet—[that] may be an area of future research.”