The Lilac Device Trial (IMPACT)

April 1, 2026 updated by: Luminate Medical, Inc.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ireland
    • Dublin
      • Dublin, Dublin, Ireland
        • Recruiting
        • St. James Hospital
        • Principal Investigator:
          • Professor Maeve Lowery
  • United States
    • California
      • Poway, California, United States, 92064
        • Withdrawn
        • Palomar Health (Topography)
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Recruiting
        • Eastern Connecticut Hematology Oncology
        • Principal Investigator:
          • Dr. Dennis Slater
    • Florida
      • Hialeah, Florida, United States, 33013
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Hawaii Cancer Care
        • Contact:
        • Principal Investigator:
          • Dr. Ashley Springer
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • Hope and Healing Cancer Services
        • Contact:
        • Principal Investigator:
          • Dr. Srilata Gundala
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Cancer Institute
        • Principal Investigator:
          • Dr. Joseph McCollom
    • Minnesota
      • Minneapolis, Minnesota, United States, 55426
        • Recruiting
        • Health Partners Frauenshuh Cancer Center
        • Contact:
        • Principal Investigator:
          • Dr. Rachel Lerner
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • Fairview Masonic Cancer Clinic, University of Minnesota
        • Principal Investigator:
          • Dr. Melissa Geller
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Astera Cancer Care
        • Contact:
        • Principal Investigator:
          • Dr. Siu-Long Yao
    • New York
      • New York, New York, United States, 11967
        • Recruiting
        • New York Cancer and Blood Specialists
        • Principal Investigator:
          • Dr. Richard Zuniga
    • Ohio
      • Springfield, Ohio, United States, 45502
        • Recruiting
        • Springfield Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Dr. Zaw Min Bo
      • Youngstown, Ohio, United States, 44512
        • Recruiting
        • Mercy Health St. Elizabeth Hospital
        • Contact:
        • Principal Investigator:
          • Dr. James Kim
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt-Ingram Cancer Center
        • Principal Investigator:
          • Dr. Rajiv Agarwal
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Hospital Sisters Health System - St.Vincent & St.Mary's
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr. Brian Burnette

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

        • Paclitaxel weekly
        • Paclitaxel every 3 weeks

      • Chemotherapy regimens based on Paclitaxel + Carboplatin

        • Paclitaxel weekly with Carboplatin weekly/every 3 weeks
        • Paclitaxel every 3 weeks with Carboplatin every 3 weeks
    • Concurrent administration of the chemotherapies listed in the inclusion criteria with or without targeted agents/immunotherapy at standard doses is allowed (such as trastuzumab, pertuzumab, bevacizumab, pembrolizumab or other immune checkpoint inhibitors).
  3. Hands and feet size within the specified study sizing range.
  4. Plan to complete taxane- or platinum-based chemotherapy in ≤ 12 months.
  5. ECOG performance status 0 - 2.
  6. Willing and able to sign informed consent.

  7. Willing to comply with and tolerate all study procedures including:

    • Wearing the Lilac Glove and Boot devices for the prescribed duration (devices to be fitted before infusion, and worn during infusion and for up to one (1) hours post infusion),
    • Complete all study related questionnaires.
  8. Participants must be able to complete participant specific questionnaires in the languages available to the study

Exclusion Criteria:

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.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
Device: Sham 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.
Experimental: Treatment
Device: The Lilac 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
From first chemotherapy and device treatment to 12 weeks post treatment one
Occurrence of clinically meaningful CIPN symptoms in the hands only at week 12 of treatment
Time Frame: From first chemotherapy and device treatment, to 12 weeks post treatment one
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)
From first chemotherapy and device treatment, to 12 weeks post treatment one

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luminate Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

August 19, 2025

First Submitted That Met QC Criteria

August 19, 2025

First Posted (Actual)

August 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CLIN-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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