The Lilac Device Trial (IMPACT)

Luminate Medical, Inc.

Status: Enrolling

Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)

Treatments: Device: The Lilac Device; Device: Sham device

Study type: Interventional

Funder types: Industry

Identifiers

NCT07142304

CLIN-53

Details and patient eligibility

About

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

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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142 participants in 2 patient groups

Treatment

Experimental group

Treatment:

Device: The Lilac Device

Control

Sham Comparator group

Treatment:

Device: Sham device