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了患者的生活质量，增加了疲劳、焦虑，并增加了医疗保健服务的成本。生姜(生姜)在传统的民间医药中已经被用来治疗各种人群的恶心和呕吐。生姜阻断5-HT3受体的能力和它在肠道中清除自由基的能力表明，生姜可能有助于降低化疗引起的恶心和呕吐的患病率和严重程度。尽管生姜在降低化疗引起的恶心和呕吐的患病率和严重程度方面可能有好处，但还没有进行剂量和/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(100 mg、500 mg、1000 mg或1500 mg，口服/天)生姜提取物(标准化为5%姜酚)在接受化疗(顺铂或阿霉素)的患者中的有效性和安全性，这些患者经历了至少一次化疗引起的恶心和呕吐，尽管传统药物治疗是最佳的。这项研究的主要目的是确定姜粉最有效的剂量，以降低急性恶心和呕吐的患病率和严重程度。这项研究的次要目标包括：(1)确定减少延迟性恶心和呕吐的发病率和严重程度的最有效剂量的姜粉；(2)评估不同剂量的口服姜根在接受化疗的患者中的安全性；以及(3)确定研究参与者是否能辨别他们正在接受安慰剂还是生姜。接受阿霉素或顺铂进行癌症相关治疗的参与者将被随机分配，在化疗前立即接受四种剂量的姜粉或安慰剂。参与者将在输液后被跟踪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.