Trial in Progress
Aims: Chemotherapy-induced peripheral neuropathy (CIPN) is recognised as a potentially permanent side effect of chemotherapy and can lead to functional disability and require cessation of chemotherapy, potentially limiting treatment success. There is limited understanding of the mechanisms responsible for CIPN and currently no preventative or curative treatment. The aim is to identify the most sensitive method to accurately evaluate CIPN severity and outcome in patients receiving neurotoxic chemotherapies and to evaluate if cryotherapy during treatment reduces this outcome.
Methods: This investigation is a cross sectional and prospective, longitudinal study of nerve function in chemotherapy treated patients. The previously published data described historical cohorts who underwent a battery of clinical, psychophysical and neurophysiological assessments while undergoing chemotherapy but without cryotherapy intervention.
In the cryotherapy sub study, we aim to recruit 150 participants who will undergo cryotherapy during chemotherapy. They will have a nerve assessment, including relevant medical history, standard physical examination and questionnaires about neuropathy symptoms. Ice gloves and ice socks will be worn for the duration of chemotherapy. Assessments will include calibrated fibre fingertip sensation, sensation of grooved plastic discs, fine motor task of filling small pegs into a board and lifting a small object to a given height, nerve conduction studies, nerve excitability studies and skin wrinkle assessment. These will be undertaken at baseline, mid treatment and final treatment as well as follow-up assessments after completion of chemotherapy to determine changes in nerve function during and at the end of chemotherapy treatment. The 150 patients in this sub study will be compared to historical cohorts who did not receive cryotherapy to evaluate differences.