This study aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy.
The name of the device used in this research study is:
-Paxman Limb Cryocompression System (PLCS)
Adults > 18 years of age
Gynecologic or breast malignancy
Weekly paclitaxel x 12 or weekly paclitaxel/carboplatin x 12, Q2 weeks paclitaxel X4 (preceded by doxorubicin/cyclophosphamide). (Breast Oncology)
Q3 weeks paclitaxel/carboplatin X 6-8 (GYN)
Previous exposure to neurotoxic chemotherapy
Pre-existing neuropathy
History of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, peripheral arterial ischemia, or sickle cell disease
Undergoing desensitization
Parallel
Paxman Limb Cryocompression System
DeviceAn investigational device designed to provide controlled cooling and compression to participant limbs during chemotherapy administration. The device is comprised of a control unit, connecting hose, and two limb wraps. The customizable limb wraps delivers continuous-flow cooling-and-compression to participant extremities
Change in Patient-Reported CIPN Symptoms Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy module at End of Treatment
Chemotherapy-induced peripheral neuropathy (CIPN) will be assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy module (EORTC QLQ-CIPN20). This aim is defined as evaluating the incidence and severity of subjectively reported CIPN symptoms, including numbness, tingling, and pain in hands and feet. Clinically significant CIPN is expected to emerge during taxane-based treatment and will be captured at the follow-up visit post-treatment.
Duration of Cryocompression Tolerated During Neurotoxic Chemotherapy
Tolerance of cryocompression will be defined by the total amount of time (in minutes) the participant is able to wear cryocompression devices during chemotherapy infusions. This aim evaluates feasibility and tolerability from the patient perspective, based on self-reported ability to continue cryocompression throughout the infusion. Early removal or shortened wear time due to discomfort will be recorded.
Incidence of Core Temperature Decrease >1°F and Skin Intolerance Symptoms Associated with Cryocompression
This aim assesses the physiological safety of cryocompression. Core body temperature will be monitored orally before, during, and after cryocompression application, with any decreases greater than 1°F considered significant. Skin will be evaluated for intolerance signs (e.g., white or greyish-yellow discoloration, pain, tingling, numbness, or pressure) on cryocompressed limbs. The aim is defined as the absence of these adverse effects during cryocompression use.
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