Actively Recruiting
The Lilac Device Trial
Led by Luminate Medical, Inc. · Updated on 2026-04-02
142
Participants Needed
15
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
The Lilac Device Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 or older diagnosed with solid tumor cancer and planned for neo-adjuvant or adjuvant chemotherapy
- Planned intravenous chemotherapy with at least 4 cycles without planned surgery pause
- Chemotherapy regimens based on Oxaliplatin (FOLFOX or FOLFIRINOX), single-agent Paclitaxel, or Paclitaxel with Carboplatin
- Concurrent use of targeted agents or immunotherapy at standard doses allowed
- Hands and feet size within specified study sizing range
- Plan to complete taxane- or platinum-based chemotherapy within 12 months
- ECOG performance status between 0 and 2
- Willing and able to sign informed consent
- Willing to wear the Lilac devices as prescribed and complete all study questionnaires
- Able to complete questionnaires in the languages available to the study
You will not qualify if you...
- Existing peripheral neuropathy of any kind at baseline (NCI CTCAE v5.0 grade > 0)
- Prior neurotoxic chemotherapy in the previous 1 year
- Positive pregnancy test for participants with childbearing potential
- Known or suspected allergy to components of the Lilac devices including natural rubber latex
- Open wounds, sores, cysts, or injuries on hands, feet, or areas where devices will be applied
- Clinically significant peripheral arterial ischemia
- Untreated or uncontrolled hypertension
- Poorly controlled diabetes
- Weight over 140 kg at enrollment
- History or suspicion of hand or foot metastasis
- Use of other investigational devices or active compression/cryotherapy for CIPN during the study
- Receiving neuropathy-directed systemic therapies at enrollment (e.g., Pregabalin, Gabapentin, Amitriptyline, Nortriptyline, Venlafaxine, Duloxetine)
- Cognitive impairment, psychiatric conditions, or mobility limitations preventing study compliance
- Current or recent participation in a clinical study affecting peripheral neuropathy
- Prior participation in this study at an earlier stage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Palomar Health (Topography)
Poway, California, United States, 92064
Withdrawn
2
Eastern Connecticut Hematology Oncology
Norwich, Connecticut, United States, 06360
Actively Recruiting
3
Hialeah Hospital
Hialeah, Florida, United States, 33013
Actively Recruiting
4
Hawaii Cancer Care
Honolulu, Hawaii, United States, 96813
Actively Recruiting
5
Hope and Healing Cancer Services
Hinsdale, Illinois, United States, 60521
Actively Recruiting
6
Parkview Cancer Institute
Fort Wayne, Indiana, United States, 46845
Actively Recruiting
7
Health Partners Frauenshuh Cancer Center
Minneapolis, Minnesota, United States, 55426
Actively Recruiting
8
Fairview Masonic Cancer Clinic, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
9
Astera Cancer Care
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
10
New York Cancer and Blood Specialists
New York, New York, United States, 11967
Actively Recruiting
11
Springfield Regional Cancer Center
Springfield, Ohio, United States, 45502
Actively Recruiting
12
Mercy Health St. Elizabeth Hospital
Youngstown, Ohio, United States, 44512
Actively Recruiting
13
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
14
Hospital Sisters Health System - St.Vincent & St.Mary's
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
15
St. James Hospital
Dublin, Dublin, Ireland
Actively Recruiting
Research Team
L
Lalita K Kota, M.S.
CONTACT
B
Barbara Oliveira, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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