The utility of DHL-HisZnNa, a novel antioxidant, against anticancer agent-induced alopecia in breast cancer patients: a multicenter phase II clinical trial.

Abstract

PURPOSE:

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.

METHODS:

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.

RESULTS:

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%).

CONCLUSIONS:

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.

• Authors: Noriko Sagawa, Shinji Ohno, Takahiro Hiratsuka, Naoto Kondo, Hiroji Iwata, Hiroko Bando, Tetsuji Ohyama, Mayumi Ishida, Yohei Kono, Kentaro Nakajima, Shinichiro Empuku, Setsuko Nishikawa, Yoshiko Irie, Masafumi Inomata, Seigo Kitano
• Journal: Breast cancer research and treatment (Breast Cancer Res Treat) Vol. 176 Issue 3 Pg. 625-630 (Aug 2019) ISSN: 1573-7217 [Electronic] Netherlands
• PMID: 30806921 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Antineoplastic Agents
• Antioxidants
• Coordination Complexes
• N-(6,8-dimercaptooctanoyl)-2-aminoethanesulfonic zinc complex
• Thioctic Acid

Topics

• Adult
• Aged
• Aged, 80 and over
• Alopecia (diagnosis, drug therapy, etiology)
• Antineoplastic Agents (adverse effects, therapeutic use)
• Antioxidants (administration & dosage, chemistry, therapeutic use)
• Breast Neoplasms (complications, diagnosis, drug therapy)
• Combined Modality Therapy
• Coordination Complexes (administration & dosage, chemistry, therapeutic use)
• Female
• Humans
• Middle Aged
• Molecular Structure
• Thioctic Acid (administration & dosage, analogs & derivatives, chemistry, therapeutic use)
• Treatment Outcome
• Young Adult