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Tests treatment safety and results for Chemotherapy Induced Peripheral Neuropathy (CIPN)
Official title The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study
ClinicalTrials.gov ID: NCT07142304
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- 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...
- 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...
See the full eligibility criteria
Who can 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
- 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 with or without targeted agents/immunotherapy at standard doses is allowed (such as trastuzumab, pertuzumab, bevacizumab, pembrolizumab or other immune...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Poway, California, United States
- Norwich, Connecticut, United States
- Hialeah, Florida, United States
- Honolulu, Hawaii, United States
- Hinsdale, Illinois, United States
- Fort Wayne, Indiana, United States
- Minneapolis, Minnesota, United States
- East Brunswick, New Jersey, United States
- Mullica Hill, New Jersey, United States
- Vineland, New Jersey, United States
- New York, New York, United States
- Springfield, Ohio, United States
- Youngstown, Ohio, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Green Bay, Wisconsin, United States
- Dublin, Dublin, Ireland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poway, California, United States; Norwich, Connecticut, United States; Hialeah, Florida, United States; Honolulu, Hawaii, United States; Hinsdale, Illinois, United States; Fort Wayne, Indiana, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.