SCALP: scalp cooling to prevent hair loss during chemotherapy for early breast cancer

SCALP was a multicentre randomised trial at seven US centres of the Paxman Orbis scalp cooling system in women with stage I or II breast cancer receiving at least four cycles of taxane-based, anthracycline-based or combined chemotherapy, randomised 2:1 to cooling or no cooling. The primary endpoint was hair preservation, defined as Dean scale grade 0 or 1 (less than 50 percent hair loss without the need for a wig) after four cycles.

At the planned interim analysis of 142 evaluable women, 48 of 95 (50.5 percent) in the cooling group preserved their hair compared with 0 of 47 in the control group, and the trial stopped early for efficacy. Preservation was better with taxane-only regimens than with anthracycline-containing regimens. Adverse events were mild (headache, chills, scalp pain) and there were no scalp metastases during follow-up. Quality-of-life measures did not differ significantly at four cycles. A companion single-arm study of the DigniCap system (Rugo et al., same issue) reported hair preservation in 66.3 percent of women on non-anthracycline taxane regimens versus none of 16 concurrent controls. Together the two studies underpinned FDA clearance of both devices for solid tumours.