Chemotherapy Induced Peripheral Neuropathy (CIPN)IMPACTNCT07142304
The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study
A study testing The Lilac Device in people with Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Luminate Medical, Inc. at 18 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy (CIPN)
- What is being tested?
- The Lilac Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 3 Oct 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
- 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:
- 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.
- Participants must be able to complete participant specific questionnaires in the languages available to the study
Who cannot join
- 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.
- 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.
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- 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 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.
- 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.
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 2 countries
United States17 sites, 16 recruiting
- Recruiting
Astera Cancer Care
East Brunswick, New Jersey, 08816
Percy Yeung, 732 387 3378, Percy.yeung@asterahealthcare.org
Dr. Siu-Long Yao
- Recruiting
Parkview Cancer Institute
Fort Wayne, Indiana, 46845
Dr. Joseph McCollom
- Recruiting
Hospital Sisters Health System - St.Vincent & St.Mary's
Green Bay, Wisconsin, 54301
Jessica Franzke, 920-433-8795, Jessica.Franzke@hshs.org
brian.burnette@hshs.org
- Recruiting
Hialeah Hospital
Hialeah, Florida, 33013
Adrian Almarales, 833-489-4968, aalmarales@bioresearchpartner.com
Dr. Luis Rangel
- Recruiting
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
Ava Baftirovska, (630) 560-0121, abaftirovska@hopenheal.care
Dr. Srilata Gundala
- Recruiting
Hawaii Cancer Care
Honolulu, Hawaii, 96813
Isobel Webster, 808-524-6115, isobel.webster@AONcology.com
Dr. Ashley Springer
- Recruiting
Health Partners Frauenshuh Cancer Center
Minneapolis, Minnesota, 55426
Jacquelyn Christenson, 612-341-4800, jacquelyn.christenson@parknicollet.com
Dr. Rachel Lerner
- Recruiting
Fairview Masonic Cancer Clinic, University of Minnesota
Minneapolis, Minnesota, 55455
Dr. Melissa Geller
- Recruiting
Inspira Medical Center Mullica Hill
Mullica Hill, New Jersey, 08062
Dr. Erev Tubb
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Dr. Rajiv Agarwal
- Recruiting
New York Cancer and Blood Specialists
New York, New York, 11967
Dr. Richard Zuniga
- Recruiting
Eastern Connecticut Hematology Oncology
Norwich, Connecticut, 06360
Dr. Dennis Slater
- Recruiting
Providence Cancer Institute
Portland, Oregon, 97213
Dr. David Page
- Withdrawn
Palomar Health (Topography)
Poway, California, 92064
- Recruiting
Springfield Regional Cancer Center
Springfield, Ohio, 45502
Tracy Adrian, 937-323-5554, tadrian@sorcc.org
Dr. Zaw Min Bo
- Recruiting
Inspira Health - Vineland
Vineland, New Jersey, 08360
Dr. Mylene Go
- Recruiting
Mercy Health St. Elizabeth Hospital
Youngstown, Ohio, 44512
Jo Wilms, 330-240-4616, JWilms@mercy.com
Dr. James Kim
Ireland1 site, 1 recruiting
- Recruiting
St. James Hospital
Dublin, Dublin
Professor Maeve Lowery
About this study
Official title: IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study
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
- Being tested
- The Lilac Device, Sham device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Lilac DeviceDevice
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.
Sham deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: The Lilac Device |
| Control | Sham comparator | Not described Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: From first chemotherapy and device treatment, to 12 weeks post treatment one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start3 Oct 2025
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luminate Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142304
- Sponsor's protocol ID
- CLIN-53
- Acronym
- IMPACT
- Status last verified
- Jun 2026
- First submitted
- 19 Aug 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study
- ClinicalTrials.gov ID
- NCT07142304
- Acronym / sponsor ID
- IMPACT / CLIN-53
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Luminate Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: The Lilac Device |
| Control | Sham comparator | Device: Sham device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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,
- Hands and feet size within the specified study sizing range.
- Plan to complete taxane- or platinum-based chemotherapy in ≤ 12 months.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Lilac DeviceThe 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. | Device | Treatment |
| Sham deviceThe 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. | Device | Control |
Primary outcome
Occurrence of clinically meaningful overall CIPN symptoms at week 12 of treatment
Time frame: From first chemotherapy and device treatment to 12 weeks post treatment one
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).
Occurrence of clinically meaningful CIPN symptoms in the hands only at week 12 of treatment
Time frame: From first chemotherapy and device treatment, to 12 weeks post treatment one
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Lilac Device in people with Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Luminate Medical, Inc. at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lalita K Kota, M.S. (703-314-6032, LALITA.KOTA@LUMINATEMED.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of clinically meaningful overall CIPN symptoms at week 12 of treatment (time frame: From first chemotherapy and device treatment to 12 weeks post treatment one). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.