The Lilac Device Trial

Exclusion Criteria

• •1. Baseline peripheral neuropathy of any kind as defined by NCI CTCAE v5.0 grade \> 0.
• •2. 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).
• •3. Positive pregnancy test at baseline for participants with child bearing potential, as per standard of care.
• •4. 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.
• •5. Any open wounds, sores, cysts or injury on the participant's hand or on part of the upper arm where the device will be applied or on the participant's feet or part of the lower leg where the device will be applied, which in the opinion of the investigator will not be healed prior to infusion commencing or who in the opinion of the investigator will be inappropriate for inclusion in this study.
• •6. Clinically significant peripheral arterial ischemia, as per standard of care, in the opinion of the investigator.
• •7. Untreated or uncontrolled hypertension, as per standard of care.
• •8. Poorly controlled diabetes, as per standard of care, in the opinion of the investigator.
• •9. Weight greater than 140 kg at the time of enrollment.
• •10. An existing history or suspicion of presence of hand or foot metastasis.
• •11. Use of other investigational devices or active compression/ cryotherapy interventions for CIPN prevention or management during the study.
• •12. Participants who are receiving neuropathy directed systemic therapies at the time of enrollment, namely, Pregabalin, Gabapentin, Amitriptyline, Nortriptyline, Venlafaxine, Duloxetine.
• •13. Participants who, in the opinion of the investigator, will be inappropriate for inclusion into this study or will not comply with the requirements of the study.
• •14. Participants with cognitive impairment, psychiatric conditions, or mobility limitations that would prevent compliance with study procedures (e.g., inability to wear the device, complete questionnaires, or attend follow-up visits).
• •15. Current participation in a clinical study or within the last 30 days prior to screening that may cause peripheral neuropathy.
• •16. Participation in this study at an earlier stage.