Effect of scalp cooling on alopecia in women undergoing chemotherapy for breast cancer. The SCALP trial

A multicentre, randomised, non-blinded study on women undergoing chemotherapy for Stage I or II breast cancer treatment in the adjuvant or neo-adjuvant setting. Patients were randomly assigned scalp cooling or no scalp cooling on a 2:1 ratio.

Type of chemotherapy: both taxane and anthracycline regimens included.

Method of scalp cooling: Paxman Scalp Cooler (Orbis). The data are from 3 sets of alopecia assessments using the CTCAE scale v4.0 by clinicians (blinded and unblinded to treatment assignment) and a self-assessment by the participant. Patients were also asked if they needed to use a wig or head covering. Success was defined as no hair loss (CTCAE grade 0) or less than 50% hair loss (grade 1) not requiring a wig; failure was defined as more than 50% hair loss, requiring a wig or head covering. The scalp cooling group completed a comfort assessment after each treatment. Patients were also asked questions about quality of life, hospital anxiety, depression and body image at baseline, after four cycles of chemotherapy and at the end of their treatment. Patients will have routine follow up visits for 5 years after finishing treatment to assess safety and overall survival.

182 patients were assigned a group in this trial. Of these, 95 scalp cooling patients completed the first chemotherapy cycle, as did 47 in the non-scalp cooling group. 89 and 45 patients completed treatment to the fourth cycle in the scalp cooling and non-scalp cooling groups respectively.

Success rates were statistically higher in the scalp cooling group compared to the control group. The difference in success rate between the two groups was 50.5%, giving patients a significantly better chance at retaining their hair if scalp cooling is used with chemotherapy treatment. Analysis showed that of the successful 50.5% of patients in the cooling group, 5 patients had grade 0 alopecia and 43 patients had grade 1 alopecia. The success rates between drug regimens varied significantly. A post hoc analysis estimated the overall success rates for two different drug categories. * An update from the authors of this paper was presented at ASCO. It was shown that the difference in success rates between the cooling and non-cooling groups had improved to 53.1%. Within the cooling group, it was shown that the success rates for taxanes and anthracyclines were 63% and 24.1%. Both of which are above the values in the post hoc analysis (Nangia, et al. ASCO Poster 2017).

No significant difference was found in the change in emotional and social functioning and patient body image, between the patients in the cooling group (with and without hair preservation) and the control group after 4 cycles of chemotherapy.

No serious adverse events were reported. 54 minor adverse events were reported including: chills, dizziness, headache, nausea, paraesthesia, pruritus, sinus pain, skin and subcutaneous tissue disorder and skin ulceration. The majority of patients reported feeling comfortable, reasonably comfortable or very comfortable. 6 patients discontinued scalp cooling treatment due to intolerance.

The results varied between sites which could be due to differences in cap fitting, and type of drug regimen used, therefore, overall some sites may have a success rate of above or below 50%. The patients were assessed for hair retention after 4 cycles; patients receiving more than 4 cycles may have seen further hair loss.
The cap fit is thought to be critical to the success of retaining hair with scalp cooling. As the clinicians became more familiar with the caps the process is thought to have improved, giving a higher chance of better success rates.