Paxman AB (publ) announced they have been selected by the SWOG Cancer Research Network, an independent global cancer research community that designs and conducts publicly funded clinical trials, for the Paxman Limb Cryocompression System (PLCS) to be used in a prospectively designed study looking at prevention of Chemotherapy-Induced Peripheral Neuropathy (CIPN). SWOG, a consortium of academic institutions, hospitals, community hospitals, community-based physician cooperatives, and individual physician offices, is one of five network groups comprising the National Cancer Institute (NCI) National Clinical Trials Network (NCTN) and as such conducts adult cancer clinical trials sponsored and approved by the NCI. The recently published ASCO and ESMO guidelines highlight cryotherapy and compression as promising interventions, but neither is recommended due to lack of efficacy data from rigorous randomized trials.

Preliminary evidence suggests that continuous-flow cryotherapy (with or without cyclic compression) and continuous compression therapy, compared to frozen gloves and socks, may be safer, more tolerable, and easier to implement on a large scale. Thus, it is important to rigorously evaluate these modalities in a randomized controlled trial. In this cooperative group study, participants scheduled to receive taxane-based therapy will be randomly assigned to receive either 1) cryocompression therapy; 2) continuous compression therapy; or 3) low cyclical pressure alone.

Participants will be randomized in a 1:1:1 fashion to cryocompression, continuous compression, or low cyclic compression to all extremities, to be administered for 30 minutes prior to taxane therapy, during taxane therapy, and for 30 minutes after completion of taxane therapy. The study aims to enrol 777 patients. PLCS devices will be shipped in January to a minimum of 25 locations, with an aim to open the study to enrolment in first quarter 2023.