Actively Recruiting
IMPACT: Clinical Investigation of Advanced Compression Technology to Improve Chemotherapy-Induced Peripheral Neuropathy - Safety and Efficacy Study
Led by Luminate Medical, Inc. · Updated on 2026-04-02
142
Participants Needed
15
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chemotherapy drugs used to treat cancer can cause a side effect called chemotherapy-induced peripheral neuropathy (CIPN), which affects the nerves in the hands and feet. Researchers are evaluating the Lilac Glove and Boot devices that apply gentle pressure to the hands and feet to reduce chemotherapy reaching peripheral nerves. This study aims to assess whether these devices can help prevent moderate to severe nerve symptoms during chemotherapy treatment for patients with solid tumors. Participants will be randomly assigned to receive either the Lilac Device, which must be worn continuously during chemotherapy infusion and for up to two hours afterward, or a sham device that looks similar but applies less pressure. The devices are fitted and activated by healthcare professionals before chemotherapy starts. The study includes adults receiving specific chemotherapy regimens based on Oxaliplatin or Paclitaxel, with or without targeted therapies. During the study, participants will wear the devices during chemotherapy infusions and complete questionnaires about nerve symptoms. Researchers will monitor for nerve symptoms at 12 weeks after starting treatment, focusing on overall symptoms and those affecting the hands. The study will track safety, device use, and symptom progression, with participation lasting through the chemotherapy period and follow-up. All study visits and questionnaires will help determine the device's impact on nerve health during chemotherapy.
CONDITIONS
Brief Title
The Lilac Device Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with diagnosed solid tumor cancer
- Planned intravenous chemotherapy with at least 4 cycles and no planned surgery pause
- Receiving specific chemotherapy regimens based on Oxaliplatin or Paclitaxel
- Concurrent use of targeted agents or immunotherapy allowed
- Hands and feet size within study device 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 during and after infusion as prescribed
- Able to complete study questionnaires in available languages
You will not qualify if you...
- Existing peripheral neuropathy (grade > 0)
- Neurotoxic chemotherapy treatment within the past 1 year
- Positive pregnancy test for those with childbearing potential
- Known allergy to device materials including natural rubber latex
- Open wounds, sores, or injuries on hands, arms, feet, or legs where device is applied
- Significant peripheral arterial ischemia
- Untreated or uncontrolled hypertension
- Poorly controlled diabetes
- Weight above 140 kg at enrollment
- History or suspicion of hand or foot metastasis
- Use of other investigational devices or compression therapies for neuropathy
- Current use of neuropathy medications like Pregabalin or Gabapentin
- Cognitive, psychiatric, or mobility issues preventing study compliance
- Participation in other clinical trials that may cause neuropathy within 30 days
- Previous participation in this study at an earlier stage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months, corresponding to the chemotherapy treatment duration
Participants receive the Lilac Device or a sham device worn during chemotherapy infusion to reduce the risk of peripheral neuropathy. Devices are fitted and turned on before infusion begins, worn continuously during infusion, and for up to two hours afterward.
Visits occur with each chemotherapy infusion over multiple cycles
Duration - 12 weeks post-treatment
Participants are monitored for peripheral neuropathy symptoms for 12 weeks after completing treatment with the device and chemotherapy.
Follow-up visits up to 12 weeks after treatment completion
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.
B
Barbara Oliveira, Ph.D.
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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