The Lilac Device Trial

NCT07142304 | Recruiting

• 1 other identifier: CLIN-53
• Study Type: interventional
• Target: 142
• Locations: 2 countries
• Sites: 15

Brief Summary

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

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Outcome Measures

Primary Outcomes (2)

• Occurrence of clinically meaningful overall CIPN symptoms at week 12 of treatment

  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).

  From first chemotherapy and device treatment to 12 weeks post treatment one

• Occurrence of clinically meaningful CIPN symptoms in the hands only at week 12 of treatment

  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)

  From first chemotherapy and device treatment, to 12 weeks post treatment one

Study Arms (2)

Treatment

EXPERIMENTAL

Device: The Lilac Device

Control

SHAM COMPARATOR

Device: Sham device

Interventions

The Lilac Device DEVICE

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.

Treatment

Sham device DEVICE

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this clinical investigation, participants must meet ALL the following criteria:
• Adults ≥ age 18 with diagnosed solid tumor cancer, who have been deemed appropriate for neo-adjuvant or adjuvant chemotherapy.
• 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
• Hands and feet size within the specified study sizing range.
• Plan to complete taxane- or platinum-based chemotherapy in ≤ 12 months.

You may not qualify if:

• Participants are not eligible to participate in the clinical trial if they meet ANY of the following criteria:
• Baseline peripheral neuropathy of any kind as defined by NCI CTCAE v5.0 grade \> 0.
• 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).
• Positive pregnancy test at baseline for participants with child bearing potential, as per standard of care.
• 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.
• Clinically significant peripheral arterial ischemia, as per standard of care, in the opinion of the investigator.
• Untreated or uncontrolled hypertension, as per standard of care.
• Poorly controlled diabetes, as per standard of care, in the opinion of the investigator.
• Weight greater than 140 kg at the time of enrollment.
• An existing history or suspicion of presence of hand or foot metastasis.
• Use of other investigational devices or active compression/ cryotherapy interventions for CIPN prevention or management during the study.
• Participants who are receiving neuropathy directed systemic therapies at the time of enrollment, namely, Pregabalin, Gabapentin, Amitriptyline, Nortriptyline, Venlafaxine, Duloxetine.
• 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).
• Current participation in a clinical study or within the last 30 days prior to screening that may cause peripheral neuropathy.
• Participation in this study at an earlier stage.

Sponsors & Collaborators

• Luminate Medical, Inc.: lead

Study Sites (15)

Palomar Health (Topography)

Poway, California, 92064, United States

WITHDRAWN

Eastern Connecticut Hematology Oncology

Norwich, Connecticut, 06360, United States

RECRUITING

Hialeah Hospital

Hialeah, Florida, 33013, United States

RECRUITING

Hawaii Cancer Care

Honolulu, Hawaii, 96813, United States

RECRUITING

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521, United States

RECRUITING

Parkview Cancer Institute

Fort Wayne, Indiana, 46845, United States

RECRUITING

Health Partners Frauenshuh Cancer Center

Minneapolis, Minnesota, 55426, United States

RECRUITING

Fairview Masonic Cancer Clinic, University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

RECRUITING

New York Cancer and Blood Specialists

New York, New York, 11967, United States

RECRUITING

Springfield Regional Cancer Center

Springfield, Ohio, 45502, United States

RECRUITING

Mercy Health St. Elizabeth Hospital

Youngstown, Ohio, 44512, United States

RECRUITING

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

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

Green Bay, Wisconsin, 54301, United States

RECRUITING

St. James Hospital

Dublin, Dublin, Ireland

RECRUITING

Central Study Contacts

Lalita K Kota, M.S.

CONTACT

703-314-6032; LALITA.KOTA@LUMINATEMED.COM

Barbara Oliveira, Ph.D.

CONTACT

+35 383-172-5043; barbara.oliveira@luminatemed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: October 3, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (14); IE (1)