Paxman announces the opening of a Clinical Trial with National University Hospital, Singapore, in collaboration with The N.1 Institute for Health, National University of Singapore.
The trial, “A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy”, is now listed on ClinicalTrials.gov – a database of privately and publicly funded clinical studies conducted around the world.
The study aims to investigate the safety and tolerability of limb cryocompression in preventing of Chemotherapy-induced Peripheral Neuropathy (CIPN) via the newly developed Paxman Cryocompression System (PCCS) in healthy subjects and cancer patients.
The Paxman device will be tested for its safety in delivering limb cryocompression and efficacy in improving the preservation of peripheral nerves during chemotherapy. The efficacy of prevention will be monitored using various clinical and patient-reported outcomes.
The initial arm of the trial will assess the safety and tolerability of limb cryocompression in healthy subjects and will determine the optimal temperature and pressure to be used. The occurrence or lack of core hypothermia will also be studied.
Once the optimal temperature and pressure of limb cryocompression is established in healthy subjects, a group of cancer patients will undergo limb cryocompression over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy.
The study is estimated to start this month with the completion date estimated to be September 2023. A larger randomized phase 3 efficacy study is being planned to be opened in second half of 2022.
Richard Paxman, CEO of Paxman, said, “Through this important study we hope to prove the safety and tolerability of limb cryocompression in preventing of Chemotherapy-induced Peripheral Neuropathy, which is a debilitating side effect for many cancer patients. The treatment of CIPN is an unmet and increasingly urgent clinical need, and a preventative solution will hopefully improve the quality-of-life for significant numbers of patients around the world.”