L'étude se concentre sur la recherche de moyens de prévenir un effet secondaire courant du traitement du cancer connu sous le nom de neuropathie périphérique induite par la chimiothérapie (CIPN). Cette condition implique des lésions nerveuses qui provoquent des douleurs, des picotements ou des engourdissements dans les mains et les pieds en raison des médicaments de chimiothérapie. L'étude utilise des dispositifs Lilac Glove et Boot, qui appliquent une pression douce sur les mains et les pieds, visant à réduire la quantité de chimiothérapie qui atteint et pourrait endommager les nerfs. Cette approche espère préserver la santé des nerfs et réduire la gravité de la CIPN, qui peut affecter de manière significative la qualité de vie des patients cancéreux subissant une chimiothérapie. Les participants à l'étude porteront ces gants et bottes spécialement conçus pendant les séances de chimiothérapie. La pression douce de ces dispositifs vise à protéger les nerfs des mains et des pieds des effets nocifs de la chimiothérapie. L'étude évalue la sécurité et l'efficacité de cette approche en observant si elle peut prévenir ou atténuer les symptômes de la neuropathie périphérique. Cela inclut la surveillance de tout effet secondaire ou bénéfice de l'utilisation des dispositifs, en veillant à ce que les participants ressentent un confort amélioré et une perturbation minimale du traitement.
Inclusion Criteria: To be eligible to participate in this clinical investigation, participants must meet ALL the following criteria: 1. Adults ≥ age 18 with diagnosed solid tumor cancer, who have been deemed appropriate for neo-adjuvant or adjuvant chemotherapy. 2. 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). 3. Hands and feet size within the specified study sizing range. 4. Plan to complete taxane- or platinum-based chemotherapy in ≤ 12 months. 5. ECOG performance status 0 - 2. 6. Willing and able to sign informed consent. 7. 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 two (2) hours post infusion), * Complete all study related questionnaires. 8. Participants must be able to complete participant specific questionnaires in English or Spanish. Exclusion Criteria: Participants are not eligible to participate in the clinical trial if they meet ANY of the following criteria: 1. Baseline peripheral neuropathy of any kind as defined by NCI CTCAE v5.0 grade \> 0. 2. Positive pregnancy test at baseline for participants with child-bearing potential, as per standard of care. 3. 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. 4. 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. 5. Clinically significant peripheral arterial ischemia, as per standard of care, in the opinion of the investigator. 6. Untreated hypertension, as per standard of care. 7. Poorly controlled diabetes, as per standard of care, in the opinion of the investigator. 8. Weight greater than 150 kg at the time of enrollment. 9. An existing history or suspicion of presence of hand or foot metastasis. 10. Use of other investigational devices or active compression/ cryotherapy interventions for CIPN prevention or management during the study. 11. Participants who are receiving neuropathy directed systemic therapies at the time of enrollment, namely, Pregabalin, Gabapentin, Amitriptyline, Nortriptyline, Venlafaxine, Duloxetine. 12. 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. 13. 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). 14. Current participation in a clinical study or within the last 30 days prior to screening that may cause peripheral neuropathy. 15. Participation in this study at an earlier stage.
sont désignés dans cette étude
d'être dans le groupe placebo en aveugle