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IMPACT

Lilac Glove and Boot Devices for Chemotherapy-Induced Peripheral Neuropathy Prevention

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What is being tested

The Lilac Device

+ Sham device
Device
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorLuminate Medical, Inc.
Study ContactLalita K Kota, M.S.More contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 3, 2025Actual date on which the first participant was enrolled.

The study focuses on finding ways to prevent a common side effect of cancer treatment known as chemotherapy-induced peripheral neuropathy (CIPN). This condition involves nerve damage that causes pain, tingling, or numbness in the hands and feet due to chemotherapy drugs. The study uses Lilac Glove and Boot devices, which apply gentle pressure to the hands and feet, aiming to decrease the amount of chemotherapy that reaches and potentially damages the nerves. This approach hopes to preserve nerve health and reduce the severity of CIPN, which can significantly affect the quality of life for cancer patients undergoing chemotherapy. Participants in the study will wear these specially designed gloves and boots during chemotherapy sessions. The gentle pressure from these devices is intended to protect the nerves in the hands and feet from the damaging effects of chemotherapy. The study evaluates the safety and effectiveness of this approach by observing whether it can successfully prevent or lessen the symptoms of peripheral neuropathy. This includes monitoring for any side effects or benefits from using the devices, ensuring that participants experience improved comfort and minimal disruption from the treatment.

Official TitleIMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study 
Principal SponsorLuminate Medical, Inc.
Study ContactLalita K Kota, M.S.More contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
142 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled
: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
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 two (2) hours post infusion), * Complete all study related questionnaires. 8. Participants must be able to complete participant specific questionnaires in English or Spanish. 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. Positive pregnancy test at baseline for participants with child-bearing potential, as per standard of care. 3. 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. 4. 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. 5. Clinically significant peripheral arterial ischemia, as per standard of care, in the opinion of the investigator. 6. Untreated hypertension, as per standard of care. 7. Poorly controlled diabetes, as per standard of care, in the opinion of the investigator. 8. Weight greater than 150 kg at the time of enrollment. 9. An existing history or suspicion of presence of hand or foot metastasis. 10. Use of other investigational devices or active compression/ cryotherapy interventions for CIPN prevention or management during the study. 11. Participants who are receiving neuropathy directed systemic therapies at the time of enrollment, namely, Pregabalin, Gabapentin, Amitriptyline, Nortriptyline, Venlafaxine, Duloxetine. 12. 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. 13. 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). 14. Current participation in a clinical study or within the last 30 days prior to screening that may cause peripheral neuropathy. 15. Participation in this study at an earlier stage.


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental

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.
Group II
Sham

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 Objectives
Primary Objectives

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).

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)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 

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