Abstract
BACKGROUND: Dermatologic toxicities are the common adverse events (AE) with several chemotherapy agents, but they are usually neglected in the research literature and clinical practice, and there are no clinically safe and effective methods to solve the problem. This study was to determine whether a medicinal and edible decoction YH0618 is effective in accelerating reducing chemotherapy-induced dermatologic toxicity in cancer patients who have completed chemotherapy. METHODS: This was a prospective randomized controlled trial conducted between 2015 and 2017. Cancer patients who have completed chemotherapy (received taxanes or anthracyclines or fluoropyrimidine) within two weeks were enrolled and then they were randomly divided into YH0618 decoction group (n=104) and wait-list control (n=110). The primary end points were the incidence of protocol-specified grade ≥2 dermatologic toxicities after 6-week intervention assessed using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Chinese version 4.0, and changes of fingernails color and skin color evaluated by L*a*b after 6 weeks of intervention. Secondary end points included assessment of quality of life (QOL) and fatigue, and some clinical objective indicators associated with myelosuppression, hepatotoxicity and nephrotoxicity. RESULTS: The study included 214 participants [mean (SD) age, 52.49 (9.08) years in YH0618 group and 50.44 (9.71) years in wait-list group]. At 6-week, YH0618 significantly reduced the incidence of grade ≥2 in nail discoloration [odds ratio (OR), 0.653; 95% CI, 0.5-0.9; P=0.005] and alopecia (OR, 0.776; 95% CI, 0.6-1.0; P=0.048) compared with control group. Besides, YH0618 increased the L* value and reduced the a* and b* values compared with control group, indicating that YH0618 increased the brightness and reduced hyperpigmentation. YH0618 also significantly reduced chemotherapy-induced fatigue (95% CI, 0.2-4.8; P=0.033). CONCLUSIONS: YH0618 may be a safe method in ameliorating chemotherapy-induced dermatologic toxicity especially nail discoloration, alopecia and skin hyperpigmentation, and on improving fatigue. TRIAL REGISTRATION: The trial was registered in the Chinese Clinical Trials Registry, ChiCTR-IOR-15006486.