The Lilac Device for Peripheral Neuropathy

(IMPACT Trial)

Recruiting at 6 trial locations

Overseen By Barbara Oliveira, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Luminate Medical, Inc.

Must not be taking: Pregabalin, Gabapentin, Antidepressants

Disqualifiers: Peripheral neuropathy, Pregnancy, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

142 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device called the Lilac Device, specifically the Lilac Glove and Boot, designed to help prevent chemotherapy-induced peripheral neuropathy (CIPN), a condition that causes nerve damage in the hands and feet due to chemotherapy. The device applies gentle pressure to the hands and feet during chemotherapy treatment to reduce nerve damage. People with solid tumor cancer planning to undergo specific types of chemotherapy might be suitable for this study, especially if they don't already have nerve problems. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve the quality of life for future patients.

Do I need to stop my current medications to join the trial?

If you are currently taking medications specifically for neuropathy, like Pregabalin or Gabapentin, you will need to stop them to join the trial. Other medications are not mentioned, so it's best to discuss with the trial team.

What prior data suggests that the Lilac Device is safe for peripheral neuropathy?

Research shows that the Lilac Device, which includes gloves and boots, helps people undergoing chemotherapy avoid nerve damage in their hands and feet. The device gently presses on the hands and feet, reducing the amount of chemotherapy that reaches the nerves and potentially lowering the risk of nerve damage.

Regarding safety, studies on the Lilac Device have not found any major negative effects. Since the device does not use medication, the risk of side effects is generally lower compared to drug treatments. Being non-invasive, it does not enter the body, making it easy to tolerate. While more detailed safety data from large studies is still needed, current evidence suggests that the device is safe to use during chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Lilac Device is unique because it offers a non-invasive approach to treating peripheral neuropathy, unlike most current options that rely on medications or invasive procedures. This device utilizes advanced technology to potentially provide relief by targeting nerve pathways directly, which could mean fewer side effects compared to traditional drug therapies. Researchers are excited about the possibility that the Lilac Device could offer quicker and more targeted relief for patients suffering from this condition, setting it apart from existing treatments.

What evidence suggests that the Lilac Device is effective for preventing chemotherapy-induced peripheral neuropathy?

Research shows that the Lilac Device, which includes a glove and boot, might help prevent nerve damage caused by chemotherapy. The device gently presses on the hands and feet, potentially reducing the amount of chemotherapy that reaches the nerves and possibly protecting them. Early results suggest that using the Lilac Device could lower the risk of serious nerve issues during cancer treatment. Participants in this trial will be assigned to either the treatment arm, receiving the Lilac Device, or the control arm, receiving a sham comparator. Although limited data from human trials exist, the concept behind the device offers hope for reducing painful side effects from chemotherapy. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with solid tumor cancer set for at least 4 cycles of specific chemotherapy regimens (like Oxaliplatin, FOLFIRINOX, Paclitaxel alone or with Carboplatin) can join. It's not for those who need a treatment pause for surgery.

Inclusion Criteria

I am on a chemotherapy regimen that includes Paclitaxel and Carboplatin.

I am set to receive 4 or more chemotherapy cycles without breaks for surgery.

I am receiving FOLFOX treatment every 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemotherapy along with the Lilac Glove and Boot devices to reduce CIPN symptoms

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• The Lilac Device

Trial Overview

The trial is testing the Lilac Glove and Boot devices against sham devices to see if they can prevent moderate to severe peripheral neuropathy in hands and feet by reducing chemotherapy exposure to nerves during treatment.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Group II: Control Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Luminate Medical, Inc.

Lead Sponsor

Trials

1

Recruited

90+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07142304

Study Details | NCT07142304 | The Lilac Device Trial

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.

2.

healthpartners.com

healthpartners.com/institute/research/studies/impact-a-clinical-investigation-on-improving-peripheral-neuropathy-induced-by-chemotherapy-with-advanced-compression-technology-a-safety-and-efficacy-study/

IMPACT: A Clinical Investigation on IMproving Peripheral ...

The Lilac boot and glove devices function by applying a low pressure across the hands and feet to reduce the access of chemotherapy to the nerves. The study is ...

3.

patlynk.com

patlynk.com/trial/NCT07142304

Lilac Glove and Boot Devices for Chemotherapy-Induced ...

The study focuses on finding ways to prevent a common side effect of cancer treatment known as chemotherapy-induced peripheral neuropathy (CIPN).

4.

ichgcp.net

ichgcp.net/clinical-trials-registry/NCT07142304

The Lilac Device Trial (IMPACT) - ICH GCP

Chemotherapy drugs, used in the treatment of cancer, have the potential of inducing peripheral neuropathy (PN) as a side effect.

5.

ctv.veeva.com

ctv.veeva.com/study/assessing-functional-impairments-in-patients-with-chemotherapy-induced-peripheral-neuropathy

Assessing Functional Impairments in Patients With ...

In a recent randomized clinical trial, our group demonstrated the effectiveness of electrotherapy in reducing both sensory and motor symptoms, ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07315334

Assessing Functional Impairments in Patients With ...

Patient Safety and Data Management In this cross-sectional comparison study the risk of potential harms for patients and healthy ...

7.

go.drugbank.com

go.drugbank.com/conditions/DBCOND0069503

Chemotherapy Induced Peripheral Neuropathy (CIPN) ...

The Lilac Device Trial, No drug interventions, prevention, Not Available ... Safety and Effectiveness of Magnetic Peripheral Nerve Stimulation for the Treatment ...