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，并增加医疗保健提供的成本。生姜（学名：Ginger）已被用于传统民间医学，用于治疗各种人群的恶心和呕吐。生姜阻断5-HT 3受体及其在肠道中清除自由基的能力表明，它可能有利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，但尚未进行剂量和/或安全性研究。因此，我们提出了一个双盲，安慰剂对照，五臂，随机临床试验，以评估四个剂量水平的有效性和安全性（100 mg、500 mg、1000 mg或1500 mg，口服/天）的药用植物提取物（标准化为5%姜辣素）在接受化疗的患者中（顺铂或阿霉素），尽管进行了最佳的常规药物治疗，但至少发生了一次化疗诱导的恶心和呕吐。这项研究的主要目的是确定最有效的剂量的粉末生姜根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）确定降低延迟性恶心和呕吐的患病率和严重程度的最有效剂量的生姜粉;（2）评估接受化疗的患者口服不同剂量的生姜粉的安全性;（3）确定研究参与者是否可以辨别他们接受的是安慰剂还是生姜。接受阿霉素或顺铂进行癌症相关治疗的参与者将在化疗输注前随机接受四种剂量的姜粉或安慰剂之一。将在输注后对受试者进行48小时随访，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.