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.
Parallel
The Lilac Device
DeviceThe Lilac Glove and Boot devices are wearable, non-sterile device for patients undergoing cancer treatment who wish to reduce the risk of peripheral neuropathy. Treatment with the Lilac Glove and Boot devices is administered by the healthcare professional in the healthcare environment. The Lilac Glove and Boot devices are designed for continual use; the devices must be fitted and turned on before infusion begins; the devices must be used without interruption during infusion, and for up to two (2) hours after infusion is complete.
Sham device
DeviceThe sham device will look, appear to function and worn for the same duration as the Lilac Device. The only difference between the devices is the level of compression applied.
Occurrence of clinically meaningful overall CIPN symptoms at week 12 of treatment
The occurrence of clinically meaningful overall CIPN symptoms is defined as an absolute increase of 5.06 or more points over baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Chemotherapy Induced Peripheral Neuropathy-20 (EORTC QLQ-CIPN20) score (standardized 0 - 100 scale).
Occurrence of clinically meaningful CIPN symptoms in the hands only at week 12 of treatment
The occurrence of clinically meaningful CIPN symptoms in the hands only is defined as an absolute increase of 9.60 or more points over baseline in the EORTC QLQ-CIPN20 upper extremity subscale score (standardized 0 - 100 scale)
Click on the lead sponsor to view all of their trials.
