The utility of DHL-HisZnNa, a novel antioxidant, against anticancer agent-induced alopecia in breast cancer patients: a multicenter phase II clinical trial
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Chemotherapy-induced alopecia (CIA) is a distressing adverse effect of anticancer drugs; however, there are currently no mechanisms to completely prevent CIA. In this study, we performed a clinical trial to examine whether sodium N-(dihydrolipoyl)-l-histidinate zinc complex (DHL-HisZnNa), an alpha-lipoic acid derivative, prevents CIA in patients with breast cancer.
Between July 2014 and May 2015, we performed a multi-center, single arm, clinical trial involving 103 breast cancer patients who received adjuvant chemotherapy at three medical institutions in Japan. During chemotherapy, a lotion containing 1% DHL-HisZnNa was applied daily to the patients’ scalps. The primary endpoint was the incidence of grade 2 alopecia; the secondary endpoints were the duration of grade 2 alopecia, alopecia-related symptoms, and drug-related adverse events. Alopecia was evaluated by three independent reviewers using head photographs taken from four angles.
Safety analysis was performed for 101 patients who started the protocol therapy. After excluding one patient who experienced disease progression during treatment, 100 patients who received at least two courses of chemotherapy underwent efficacy analysis. All original 101 patients developed grade 2 alopecia, the median durations of which were 119 days (112–133 days) and 203 days (196–212 days) in the groups treated with four and eight courses of chemotherapy, respectively. Mild or moderate adverse events potentially related to DHL-HisZnNa were observed in 11 patients. Alopecia-related symptoms were observed in 53 patients (52%).
The application of 1% DHL-HisZnNa to the scalp did not prevent CIA. However, this drug may promote recovery from CIA.
Trial registration number: UMIN000014840.
KeywordsAlopecia Antioxidants Chemotherapy DHL-HisZnNa
Common Toxicity Criteria for Adverse Events
Sodium N-(dihydrolipoyl)-l-histidinate zinc complex
We would like to express our sincere gratitude to Ms. C. Tomimatsu and Ms. Y. Aso of the Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, who did paperwork for the clinical trial; we also thank Drs. K. Kuroi, S. Shimizu, and T. Takano who are the members of the independent image analysis committee.
This research was funded by Research and Development Fund from Institute for Innovative Collaboration Promotion, Oita University.
Compliance with ethical standards
Conflict of interest
Oita University received Oita University Aderans Company Limited Collaboration Research Fee.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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