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Effects of improved hypoallergenic fabrics in medical wigs in patients with breast cancer with chemotherapy-induced alopecia: a randomised clinical trial

Purpose Chemotherapy causes changes in appearance in patients with cancer. Therefore, to have a normal life, it is necessary for patients to wear a wig. However, wearing a wig may strain an already sensitive scalp during chemotherapy. This study aimed to assess the effects of a hypoallergenic medical wig in breast cancer patients with chemotherapy-induced alopecia (CIA). Methods A randomised, single-blind, controlled study was conducted from January 2015 to July 2017 in Tokyo, Japan. Women with non-metastatic breast cancers were enrolled. Participants were provided a hypoallergenic medical wig or a traditional medical wig. The primary endpoint was incidence of scalp dermatitis, including erythema, rash and erosion. The secondary endpoints were incidence of scalp symptoms, alterations in scalp barrier functions and quality of life (QOL). Patients were followed at the start of the first chemotherapy administration and at 13th week. Results Fifty-nine women were included in the analysis. At 13th week, the incidence of erythema was 44.8% among patients in the intervention group and 86.7% among patients in the control group, in the intention-to-treat analysis (p<0.01). The incidence of erosion tended to decrease in the intervention group at the 13th week (p=0.09). The incidence of scalp symptoms, alterations in scalp barrier functions and QOL were not significantly different between the groups. Conclusions The incidence of dermatitis, including erythema, rash and erosion, decreased when wearing the new hypoallergenic medical wig. The gentle hypoallergenic medical wig is useful in improving erythema in cancer patients with CIA. Trial registration number UMIN000021289.