Is NCT07142304 recruiting in Hialeah, FL?

Yes, NCT07142304 is currently recruiting participants at its Hialeah, FL location. This chemotherapy induced peripheral neuropathy (cipn) clinical trial is actively enrolling qualified participants.

Is participation in this Hialeah clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Chemotherapy Induced Peripheral Neuropathy (CIPN) Clinical Trial in Hialeah, FL

Q: How do I join the chemotherapy induced peripheral neuropathy (cipn) clinical trial in Hialeah?

To join this clinical trial in Hialeah, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Chemotherapy Induced Peripheral Neuropathy (CIPN) Study in Hialeah

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

Sponsor: Luminate Medical, Inc.

Who Can Participate

Inclusion Criteria

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 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

Exclusion Criteria

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.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Hialeah?

Yes, this clinical trial (NCT07142304) has an active research site in Hialeah, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chemotherapy Induced Peripheral Neuropathy (CIPN) Treatment Options in Hialeah, FL

If you're searching for chemotherapy induced peripheral neuropathy (cipn) treatment options in Hialeah, FL, this clinical trial (NCT07142304) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Hialeah research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chemotherapy induced peripheral neuropathy (cipn) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chemotherapy induced peripheral neuropathy (cipn) clinical trials near you to find additional studies recruiting in your area.

Chemotherapy Induced Peripheral Neuropathy (CIPN) Clinical Trial in Hialeah, FL

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