Study of the Lilac Device to Prevent Chemotherapy-Induced Peripheral Neuropathy Using Advanced Compression Technology

What this Trial Is About

Chemotherapy-induced peripheral neuropathy CIPN is a side effect caused by chemotherapy drugs that affect the nerves in the hands and feet. This trial evaluates the use of the Lilac Glove and Boot devices, which apply gentle pressure to the hands and feet to reduce chemotherapy exposure to peripheral nerves. The study aims to assess the safety and potential prevention of moderate to severe neuropathy symptoms during cancer treatment. Participants are randomly assigned to either use the Lilac Device or a sham device that looks similar but applies less compression. The devices are fitted and turned on before chemotherapy infusion, worn continuously during infusion, and for up to two hours afterwards. The study focuses on patients receiving specific chemotherapy regimens based on Oxaliplatin or Paclitaxel, with or without additional targeted therapies. During the trial, participants wear the devices during chemotherapy cycles planned for up to 12 months and complete questionnaires related to neuropathy symptoms. Researchers monitor the occurrence of neuropathy symptoms at 12 weeks post-treatment, focusing on overall symptoms and those in the hands. The study also tracks safety and tolerability, with the total participation lasting through the chemotherapy period and follow-up assessments.

The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study