Concomitant limb cryocompression and scalp cooling to reduce paclitaxel-induced neuropathy and alopecia.

Abstract

e24157 Background: Scalp cooling is an FDA approved method to mitigate chemotherapy-induced alopecia (CIA) caused by paclitaxel. Chemotherapy-induced peripheral neuropathy (CIPN) is a dose limiting toxicity of paclitaxel. Several recent randomized studies have suggested limb hypothermia as a mechanism to ameliorate paclitaxel-induced neuropathy. The safety, tolerability and feasibility of concomitant limb hypothermia and scalp cooling to prevent these two common adverse effects of paclitaxel has not been previously studied. Methods: A proof-of-concept study was conducted in breast cancer patients receiving weekly paclitaxel chemotherapy. Each subject underwent concomitant scalp and four-limb cryocompression with each chemotherapy infusion (3 hours) for a maximum of 12 cycles. Limb cryocompression was administered at cyclic pressure (5-15 mmHg) and temperatures starting at 11°C (established as lowest tolerable temperature in a separate healthy volunteer study) and adjusted according to patient tolerability. Skin surface temperature and tolerance scores were recorded. CIPN was assessed via EORTC Quality of Life Questionnaire-CIPN before (QOLpre), after completion (QOLpost) and 3-months post chemotherapy (QOL3m). Results: Fifteen patients enrolled in the study, of which 14 completed all 12 cycles of concomitant scalp cooling and limb cryocompression during chemotherapy without any side effects barring transient erythema over the limbs. None had intolerance to scalp cooling. Eight patients safely tolerated 12 cycles of cryocompression at 11°C. Of the remaining, 6 completed all 12 cycles at device temperatures ranging from 14-25°C. One patient withdrew at the 6th cycle, finding 25°C intolerable. Median QOLpre was 19 (range 17-19), QOLpost 20 (18-29) (p = 0.04, Wilcoxon signed-rank) and QOL3m was 19 (18-21) (vs QOLpre; p = 1). QOL showed no significant differences from pre-chemotherapy to 3 months post-chemotherapy suggesting preservation of nerve function. Conclusions: Delivery of concomitant scalp cooling and limb cryocompression is feasible, safe and generally well-tolerated. Future limb hypothermia trials should not preclude patients from undergoing scalp-cooling concomitantly to reduce CIA. Clinical trial information: NCT03248193 .