The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Indu… (NCT07142304) | Clinical Trial Compass
RecruitingNot Applicable
The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study
United States, Ireland142 participantsStarted 2025-10-03
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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,
. Hands and feet size within the specified study sizing range.
. Plan to complete taxane- or platinum-based chemotherapy in ≤ 12 months.
. ECOG performance status 0 - 2.
. Willing and able to sign informed consent.
. Willing to comply with and tolerate all study procedures including:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of clinically meaningful overall CIPN symptoms at week 12 of treatment
Timeframe: From first chemotherapy and device treatment to 12 weeks post treatment one
2
Occurrence of clinically meaningful CIPN symptoms in the hands only at week 12 of treatment
Timeframe: From first chemotherapy and device treatment, to 12 weeks post treatment one
. Participants must be able to complete participant specific questionnaires in the languages available to the study
Exclusion 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.
. 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.
. 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.