Computer-controlled scalp cooling to prevent alopecia is currently available for patients undergoing chemo-therapy. Previous studies have suggested that the temperature should be <22°C at a depth of 1-2 mm in the scalp to prevent alopecia. However, the optimal pre-set temperature of the coolant medium to achieve this temperature requires further investigation. A pre-study was conducted to investigate which pre-set coolant temperature of 3 and 8°C was the most effective in achieving a scalp temperature of <22°C. The temperature variations at different sites of the scalp and variations within and among the participants at baseline and during the cooling procedure were also evaluated. A randomized main study was then performed to compare the efficacy and side effects of the two temperature levels during paclitaxel/carboplatin chemotherapy. A group of 5 healthy female volunteers participated in a series of scalp temperature measurements during cooling with 3 and 8°C of the coolant medium. In the randomized main study, a total of 47 patients were included, of whom 43 were evaluable after the first cycle. A pre-set temperature of 3°C tended to be the most efficient in achieving a hair follicle temperature of <22°C. The top of the head was less responsive to scalp cooling. There were no significant differences in the prevention of alopecia between the two temperatures in the main study. However, headache and a feeling of coldness were more common in the 3°C group. A coolant temperature of 3°C was more effective in achieving a subcutaneous temperature of <22°C. However, this finding was not reflected by a significant difference in the prevention of alopecia in this study, although a higher incidence of side effects was associated with a lower temperature level.
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