An Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving Chemotherapy-induced peripherAl NeurOpathy in Patients With Colon or Breast Cancer After End of Adjuvant Therapy

CIPN is a common side effect of many chemotherapeutic agents and often results in dose limitation, switch to less efficacious agents or even therapy discontinuation. CIPN mainly affects sensory nerves, while motor or autonomic nerve injury is rare. Therefore, most patients with CIPN experience numbness, tingling, hyperesthesia, loss of vibratory perception, and burning pain. Due to the vulnerability of the long nerves, CIPN typically appears in a 'stocking and glove' distribution.

Chemotherapeutic agents that cause CIPN include platinum compounds (e.g., cisplatin, oxaliplatin), antitubulins (vinca alkaloids (e.g., vincristine) and taxanes (e.g., docetaxel, paclitaxel)), proteasome inhibitors (e.g., bortezomib) and immunomodulatory drugs (e.g., lenalidomide).

Platinum compounds are known to accumulate in the dorsal root ganglion (DRG) leading to cell death in sensory neurons. DRG death may account for chronic sensory neuropathy, which manifests primarily as sensory paresthesias, dysesthesias and sensory ataxia most often located in the extremities and persists between cycles. In addition, Oxaliplatin directly regulates the gating of axonal voltage-gated sodium channels, inducing an acute neurotoxicity which is characterized by peripheral nerve hyperexcitability. Symptoms, like sensitivities to touching cold items, discomfort swallowing cold liquids, throat discomfort, and muscle cramps, occur during or shortly after the infusion.

Taxanes are known to cause disruption of microtubule function and therefore microtubule-based axonal transport. In addition, they interfere with macrophage activation in both the DRG and peripheral nerve, as well as microglial activation within the spinal cord. These effects result in a distal axonopathy also referred to as the dying-back phenomenon.

The effectiveness of OnLife® in improving CIPN is based on a patented fatty acid group (FAG) that comprises palmitoylethanolamide (PEA), alpha-linolenic acid, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), linoleic acid, oleic acid, palmitic acid, stearic acid, arachidic acid and myristic acid.