Chemotherapy drugs, used in the treatment of cancer, have the potential of inducing peripheral neuropathy (PN) as a side effect. This side effect is commonly referred to as CIPN, or chemotherapy-induced peripheral neuropathy.
The Lilac Glove and Boot devices apply a low pressure across the surface of the hands and feet, respectively, to reduce access of chemotherapy to the peripheral nerves on the hands and feet. The small amount of pressure reduces the level of chemotherapy reaching the peripheral nerves, hence increasing the likelihood of nerve preservation during treatment and thus may potentially temporarily prevent the onset of moderate to severe PN symptoms induced by chemotherapy in the hands and feet while receiving treatment
Adults ≥ age 18 with diagnosed solid tumor cancer, who have been deemed appropriate for neo-adjuvant or adjuvant chemotherapy.
Planned intravenous treatment with at least 4 cycles of chemotherapy, with no planned treatment pause for surgery,
Chemotherapy regimens based on Oxaliplatin
FOLFOX every 2 weeks
Baseline peripheral neuropathy of any kind as defined by NCI CTCAE v5.0 grade > 0.
Prior exposure to neurotoxic chemotherapy in the previous 1 year, counted as the period since the last neurotoxic chemotherapy treatment (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib).
Positive pregnancy test at baseline for participants with child bearing potential, as per standard of care.
Known or suspected allergy or hypersensitivity to any component of the Lilac Glove or Boot device that comes into contact with the study participant. Caution: This product contains natural rubber latex, which may cause allergic reactions.