HD6610 granules relieve oxaliplatin-induced peripheral neuropathy: study protocol for a multicenter randomized double-blind placebo-controlled trial

Background: Oxaliplatin, a platinum-based cytotoxic agent, is a widely used chemotherapeutic agent. Small-sample clinical trials and animal experiments have shown that Jiawei Huangqi Guizhi Wuwu Tang (a decoction of five components, including Radix Astragali and Ramulus Cinnamomi) effectively reduces peripheral neuropathy caused by oxaliplatin, but no confirmation exists from a prospective, multicenter, randomized, controlled, blinded clinical trial. Methods/Design: We plan to conduct such a trial that will be completed at the Department of Oncology, Jiangsu Provincial Hospital of Integrated Medicine, China, the Center of Oncology of Nanjing Drum Tower Hospital, China, and the Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, China. Sixty-four patients with colorectal cancer stages IIa-IV will be equally randomized into either the HD6610 granule group (oxaliplatin chemotherapy plus HD6610 granules, a granular form for Jiawei Huangqi Guizhi Wuwu Tang) or the HD6610 placebo group (oxaliplatin chemotherapy plus HD6610 placebo made of bitters, food coloring, and starch). Primary outcomes are the scores of the European Organization for Research and Treatment of Cancer′s Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy and the National Cancer Institute′s Common Terminology Criteria for Adverse Events Version 4.0. Secondary outcomes include the time of peripheral neuropathy occurrence, total neuropathy score, score of the European Organization for Research and Treatment of Cancer′s Core Quality of Life Questionnaire, and survival time. Other outcomes will be evaluated before treatment as well as 1 and 2 weeks and 2, 4, 8, 12, 16, 20, and 24 months after treatment. Discussion: This study will provide evidence that the clinical application of HD6610 can reduce oxaliplatin-induced peripheral neuropathy. Trial registration: ClinicalTrials.gov identifier: NCT02590367; registered on 14 September 2015. Ethical approval: The study protocol was approved by Jiangsu Provincial Hospital of Integrated Medicine in China (approval No. 2014ZX (KT)-010-02).