RecruitingChemotherapy Induced Peripheral Neuropathy (CIPN)

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

Eligible age

18+ yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

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About this study

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

Sponsor: Luminate Medical, Inc.

You may qualify if…

✓ To be eligible to participate in this clinical investigation, participants must meet ALL the following criteria:
✓ 1. Adults ≥ age 18 with diagnosed solid tumor cancer, who have been deemed appropriate for neo-adjuvant or adjuvant chemotherapy.
✓ 2. Planned intravenous treatment with at least 4 cycles of chemotherapy, with no planned treatment pause for surgery,
✓ With one of the following treatments:
✓ Chemotherapy regimens based on Oxaliplatin
✓ FOLFOX every 2 weeks
✓ FOLFIRINOX every 2 weeks
✓ Chemotherapy regimens based on single-agent Paclitaxel

You may not qualify if…

✕ Participants are not eligible to participate in the clinical trial if they meet ANY of the following 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.