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

Conditions

• Chemotherapy Induced Peripheral Neuropathy (CIPN)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• The Lilac Device — DEVICE
  The 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 — DEVICE
  The 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.

Study Details

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

Key Dates

Start date

Oct 3, 2025

Status verified

Jun 2026

Primary completion

Aug 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

142 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Treatment
• Sham Comparator: Control

Primary Outcome Measure

Occurrence of clinically meaningful overall CIPN symptoms at week 12 of treatment [ Time Frame: From first chemotherapy and device treatment to 12 weeks post treatment one ]

Central Contacts

• Lalita K Kota, M.S.
  703-314-6032
  [email protected]
• Barbara Oliveira, Ph.D.
  +35 383-172-5043
  [email protected]

Locations (17)

Find similar trials in Poway, CA

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