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
∙ 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