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Squeeze away chemo pain: gloves and boots may stop nerve damage

NCT ID NCT07142304

Symptom relief Sponsor: Luminate Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests special gloves and boots that gently squeeze the hands and feet during chemotherapy. The pressure may reduce how much chemo reaches the nerves, possibly preventing pain and numbness. About 142 adults with cancer will try the devices to see if they help avoid nerve damage from treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 142 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm chemotherapy-induced neuropathy prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chemotherapy induced peripheral neuropathy (CIPN)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Astera Cancer Care

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Eastern Connecticut Hematology Oncology

    RECRUITING

    Norwich, Connecticut, 06360, United States

  • Fairview Masonic Cancer Clinic, University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Hawaii Cancer Care

    RECRUITING

    Honolulu, Hawaii, 96813, United States

  • Health Partners Frauenshuh Cancer Center

    RECRUITING

    Minneapolis, Minnesota, 55426, United States

  • Hialeah Hospital

    RECRUITING

    Hialeah, Florida, 33013, United States

  • Hope and Healing Cancer Services

    RECRUITING

    Hinsdale, Illinois, 60521, United States

  • Hospital Sisters Health System - St.Vincent & St.Mary's

    RECRUITING

    Green Bay, Wisconsin, 54301, United States

  • Inspira Health - Vineland

    RECRUITING

    Vineland, New Jersey, 08360, United States

  • Inspira Medical Center Mullica Hill

    RECRUITING

    Mullica Hill, New Jersey, 08062, United States

  • Mercy Health St. Elizabeth Hospital

    RECRUITING

    Youngstown, Ohio, 44512, United States

  • New York Cancer and Blood Specialists

    RECRUITING

    New York, New York, 11967, United States

  • Palomar Health (Topography)

    WITHDRAWN

    Poway, California, 92064, United States

  • Parkview Cancer Institute

    RECRUITING

    Fort Wayne, Indiana, 46845, United States

  • Providence Cancer Institute

    RECRUITING

    Portland, Oregon, 97213, United States

  • Springfield Regional Cancer Center

    RECRUITING

    Springfield, Ohio, 45502, United States

  • St. James Hospital

    RECRUITING

    Dublin, Dublin, Ireland

  • Vanderbilt-Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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