Abstract
BackgroundChemotherapy-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).MethodsHair 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.ResultsFrom 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.ConclusionsDigniCap® 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 numberNCT03712696.
Highlights
Chemotherapy-induced alopecia (CIA) is a distressing side effect of cancer therapy
There are many toxicities associated with chemotherapy, but alopecia is the most public stigma of this treatment and it may represent a real deterrent for many patients.[1,2]
Alopecia induced by these agents is dose dependent, its severity depends on the combination of other cytotoxic agents.[4]
Summary
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). The primary efficacy endpoint was the patient self-assessment HL score evaluated at least 3 weeks after completing CT. RESULTS: From July 2014 to November 2016, 139 consecutive breast cancer patients were enrolled and received at least one treatment with scalp cooling. Alopecia is a non-life threatening but disturbing side effect of almost all effective adjuvant chemotherapy regimens for breast cancer. The degree of alopecia varies among different drugs Chemotherapeutic agents, such as the taxanes and anthracyclines, are associated with significant alopecia as one of their main side effects.
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