Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines

Abstract

BACKGROUND: Chemotherapy-induced alopecia (CIA) is a distressing side effect of cancer therapy. The trial aimed to assess feasibility and effectiveness of scalp-cooling system DigniCap® to prevent CIA in primary breast cancer patients receiving an anthracycline containing adjuvant chemotherapy (CT). METHODS: Hair loss (HL) was evaluated by patient self-assessment and by the physician according to the Dean's scale at baseline and after each cycle of CT. The primary efficacy endpoint was the patient self-assessment HL score evaluated at least 3 weeks after completing CT. A Dean's scale score of 0-2 (i.e. HL ≤50%) was considered a success. RESULTS: From July 2014 to November 2016, 139 consecutive breast cancer patients were enrolled and received at least one treatment with scalp cooling. Fifty-six out of 131 evaluated patients successfully prevented HL (43%, 95% CI: 34-51%). Twenty-four patients (32%) discontinued the scalp cooling because of alopecia or scalp-cooling related AE, three patients had missing information on CIA, and 48 patients (64%) had a HL greater than 50% after CT. No serious AEs were reported. CONCLUSIONS: DigniCap® System resulted as a promising medical device to be safely integrated in supportive care of early breast cancer patients. Longer follow-up is needed to assess long-term safety and feasibility. CLINICAL TRIAL REGISTRATION NUMBER: NCT03712696.

Reply to Comments on: “Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp cooling system in early breast cancer patients treated with anthracyclines.”

“…In fact, it is possible that medical staff underestimate the effect of hair loss as it has already been highlighted in the study by Rugo et al where it was noted that the scores reported by patients are generally lower. 1 , 2 In the Discussion of our paper, 3 we pointed out that patients who interrupted the scalp cooling system because of unsatisfactory results were 11%. In addition, only 12 patients answered the question in the EORTC-BR23 questionnaire on being upset for the hair loss, showing an increased distress overtime ( p < .01).…”

Trichopsychodermatology: The Psychiatric and Psychosocial Aspects of Hair Disorders

“…In an effort to prevent and minimize hair loss during short infusion cycles, favorable results have been reported through scalp cooling. Additionally, in a trial implementing a scalp-cooling system in 139 patients with breast cancer undergoing chemotherapy, hair loss was prevented in 43% of the patients (Munzone et al, 2019). Additionally, in a trial implementing a scalp-cooling system in 139 patients with breast cancer undergoing chemotherapy, hair loss was prevented in 43% of the patients (Munzone et al, 2019).…”

“…Specifically, cooling below 22 C can reduce the toxic effects of cytostatic agents on hair follicles (Jedličková, Vokurka, Vojtíšek, & Malečková, 2019). Additionally, in a trial implementing a scalp-cooling system in 139 patients with breast cancer undergoing chemotherapy, hair loss was prevented in 43% of the patients (Munzone et al, 2019).…”

Scalp Cooling Impact in Alopecia of Patients Under Treatment for Breast Cancer—Literature Review

“…Regarding chemotherapy protocols, the most used are the FEC (fluorouracil/epirubicin/cyclophosphamide), AC (doxorubicin/cyclophosphamide), EC (epirubicin/cyclophosphamide), TC (docetaxel/cyclophosphamide), paclitaxel (P), docetaxel (D), TAC (docetaxel/doxrubicin/cyclophosphamide), among others [5][6][7][8]. In addition, monoclonal antibodies, such as trastuzumab and pertuzumab, have also shown results in the neoadjuvant and adjuvant treatments of patients with HER-2 positive breast cancer [9,10].…”