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Lilac low-pressure glove and boot to protect nerves during chemotherapy

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

Not applicable Interventional Luminate Medical, Inc. · NCT07142304

Tests if wearing Lilac low-pressure gloves and boots during certain oxaliplatin- or paclitaxel-based chemotherapy can lessen peripheral nerve damage in adults.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment142 (estimated)
Ages18 Years and up
SexAll
SponsorLuminate Medical, Inc. Industry-sponsored
Drugs / interventionstrastuzumab, pertuzumab, bevacizumab, pembrolizumab, chemotherapy, immunotherapy
Locations15 sites (Poway, California and 14 other locations)
Trial IDNCT07142304 on ClinicalTrials.gov

What this trial studies

This randomized interventional trial compares the Lilac Glove and Boot devices, which apply low pressure to hands and feet, with a sham device during systemic chemotherapy. The devices aim to reduce delivery of chemotherapy to peripheral nerves in the hands and feet to prevent moderate-to-severe chemotherapy-induced peripheral neuropathy (CIPN). Eligible adults have solid tumors and are starting at least four planned IV cycles of oxaliplatin- or paclitaxel-based regimens, with concurrent targeted or immunotherapy allowed. Participants are enrolled at multiple U.S. community and regional sites where neuropathy symptoms and device tolerability are monitored during treatment.

Who should consider this trial

Good fit: Adults (≥18) with a solid tumor who are starting neo-adjuvant or adjuvant IV chemotherapy with at least four planned cycles of oxaliplatin- or paclitaxel-based regimens are the intended participants.

Not a fit: Patients not receiving oxaliplatin- or paclitaxel-based intravenous chemotherapy, those unable to wear the devices, or those with pre-existing severe neuropathy are unlikely to gain benefit from this intervention.

Why it matters

Potential benefit: If successful, the devices could reduce the frequency or severity of hand and foot neuropathy during chemotherapy and help preserve nerve function while patients complete treatment.

How similar studies have performed: Related approaches such as cryotherapy and scalp cooling have shown mixed results for preventing chemo-related toxicity, and low-pressure compression devices are a relatively novel approach with limited published clinical data to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Poway, California and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chemotherapy Induced Peripheral Neuropathy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.