XXXX for preventing chemotherapy-induced neuropathy - a pilot study on safety and tolerability in healthy controls.

@entity1 @entity1183 @entity0 @entity5 @entity1311 @entity1897 @entity35 @entity2332
INTRODUCTION: @entity1897 ( @entity1897 ) is a major dose-limiting side effect of several chemotherapeutic agents, often leading to treatment discontinuation. Up to 20% of @entity1 treated with weekly @entity1311 experience severe @entity1897 and no effective treatment has been established so far. The mechanisms of @entity1897 are unclear, but are directly dose-related. We had earlier demonstrated, in @entity35 , the influence of @entity2332 in reducing nerve blood flow. Here, we hypothesize that continuous flow limb @entity2332 during chemotherapy reduces the incidence and severity of @entity1897 , by limiting deliverance of the @entity1897 . In this study, prior to assessing the effect of @entity2332 in preventing @entity1897 in @entity5 subjects undergoing @entity1311 chemotherapy, we assess the safety and tolerable temperatures for limb @entity2332 in healthy @entity1 subjects. MATERIAL AND METHODS: In 15 healthy @entity1 subjects, @entity2332 was administered as continuous flow cooling, unilaterally, via a thermoregulator setup covering the digits up to the elbow/knee, along with continuous skin temperature monitoring. Thermoregulator coolant temperatures between 25     C and 20     C were tested for tolerability, based on a carefully designed temperature regulation protocol, and maintained for three hours mimicking the duration of chemotherapy. Tolerability was evaluated using various safety and tolerability scores to monitor the subjects. RESULTS: At the end of the cooling session the healthy subjects presented without significant adverse effects, the main being brief mild skin erythema and transient @entity1183 . Coolant temperatures as low as 22     C were well tolerated continuously over three hours. CONCLUSION: Our results confirm the safety and tolerability of continuous flow limb @entity2332 in healthy subjects. Further studies will use 22     C thermoregulator temperature to investigate @entity2332 in preventing @entity1897 in @entity0 @entity1 receiving adjuvant weekly @entity1311 . This pilot study may contribute to alleviating chemotherapy dose limitation due to @entity1897 and increase the likelihood of success of chemotherapy.
