Ginger Control of Chemotherapy Induced Nausea and Emesis

描述（由申请人提供）：化疗引起的恶心和呕吐显著降低患者的生活质量，增加疲劳、焦虑，并增加医疗保健服务的成本。姜（Zingiber officinalis）已经在民间医学中用于治疗各种人群的恶心和呕吐。生姜阻断5-HT3受体及其清除肠道自由基的能力表明，它可能有助于减少化疗引起的恶心和呕吐的发生率和严重程度。尽管生姜在减少化疗引起的恶心和呕吐的发生率和严重程度方面可能有好处，但没有进行剂量和/或安全性研究。因此，我们提出了一项双盲、安慰剂对照、五臂随机临床试验，以评估四种剂量水平（100mg、500mg、1000mg或1500mg，口服/天）的生姜提取物（标准为5%姜辣素）对化疗（顺铂或阿霉素）患者的疗效和安全性，这些患者在接受最佳常规药物治疗后至少经历过一次化疗引起的恶心和呕吐。本研究的主要目的是确定姜根粉的最有效剂量，以减少急性恶心和呕吐的患病率和严重程度。该研究的次要目的包括(1)确定姜根粉的最有效剂量，以减少延迟性恶心和呕吐的患病率和严重程度；(2)评价化疗患者口服不同剂量姜粉的安全性；(3)确定研究参与者是否能分辨出他们服用的是安慰剂还是生姜。接受阿霉素或顺铂癌症相关治疗的参与者将在化疗输注前立即接受四种剂量的姜粉或安慰剂中的一种。参与者将在输注后随访48小时，以评估恶心和呕吐的频率和严重程度。基线和化疗后48小时的实验室将用于评估生姜的安全性。

DESCRIPTION (provided by applicant): Chemotherapy induced nausea and vomiting significantly reduces patients' quality of life, increases fatigue, anxiety, and increases costs of health care delivery. Ginger (Zingiber officinalis) is already used in traditional folk medicine to treat nausea and vomiting in various populations. Ginger's ability to block 5-HT3 receptors and its free-radical scavenging in the intestines suggest that it may be beneficial for reducing both the prevalence and severity of chemotherapy induced nausea and vomiting. Despite ginger's possible benefits in reducing the prevalence and severity of chemotherapy induced nausea and vomiting, no dosing and/or safety studies have been performed. Therefore we propose a double-blind, placebo-controlled, five-armed, randomized clinical trial to assess the efficacy and safety of four dose levels (100 mg, 500 mg, 1000 mg, or 1500 mg, orally/day) of Zingiber officinalis extract (standardized for 5% gingerols) in patients undergoing chemotherapy (cisplastin or adriamycin) who have experienced at least one episode of chemotherapy induced nausea and vomiting despite optimal conventional medical therapy. The primary aim of the study is to determine the most efficacious dose of powdered ginger-root for reducing the prevalence and severity of acute nausea and vomiting. Secondary aims of the study include (1) determination of the most efficacious dose of powdered ginger-root for reducing the prevalence and severity of delayed nausea and vomiting; (2) assessment of the safety of different doses of oral powdered ginger root in patients receiving chemotherapy; and (3) determination if study participants can discern if they are receiving placebo or ginger. Participants receiving either adriamycin or cisplatin for cancer related treatment will be randomized to receive one of four doses of powdered ginger or placebo immediately prior to chemotherapy infusion. Participants will be followed for 48 hours after infusion in order to assess frequency and severity of nausea and vomiting. Baseline and 48 hour post chemotherapy labs will be used to assess safety profile of ginger.