Abstract
Purpose
Chemotherapy with anthracyclines, taxanes, or alkylating agents often causes cutaneous side effects. Nonspecific inhibition of the proliferative activity of keratinocytes has antidifferentiation effects that lead to defects in the barrier function and, thus, to dry, itchy, and irritable skin. These cutaneous symptoms reduce the quality of life of the patients considerably. Conditioning with topical application of niacinamide uses the cytoprotective and barrier stabilizing effect of vitamin B3.
Patients and methods
A multicenter randomized crossover study investigated the influence of the test preparation on the quality of life compared to standard care for 73 patients with breast cancer undergoing adjuvant or neoadjuvant cytostatic therapy. Primary target parameter was the Dermatology Life Quality Index with its respective subscales after 6 weeks of a twice-daily application of the respective preparations. Additionally, specific symptoms such as pruritus, dryness, and irritability have been assessed using visual analog scales.
Results
Regarding the total score of the Dermatology Life Quality Index, no relevant differences could be observed. However, the results for the “symptoms and feelings” subscale show a significant advantage in favor of the test preparation. Significant superiority of the test preparation could also be observed in the secondary target parameters, the visual analog scales (P<0.05).
Conclusion
The results show for the first time a significant superiority of prophylactic application of niacinamide for maintaining quality of life while undergoing cytostatic treatment.
Acknowledgments
The authors wish to thank Ms Andrea Stennett for excellent assistance in study management and Dr Gerd Franke for biometrical evaluation.
Disclosure
The study was fully sponsored by La Roche-Posay Laboratoire Dermatologique L’Oréal Deutschland GmbH Georg-Glock-Straße 18 40474 Düsseldorf, Germany. J Wohlrab and D Lüftner received lecture fees, were co-operation partners in scientific projects and investigators in clinical studies sponsored by L’Oréal Deutschland GmbH. R Richter and S Seite are employed by the sponsor. The other authors were investigators in this clinical study sponsored by L’Oréal Deutschland GmbH and declare no conflict of interest.