ACTRN12619000368134尚未招募4 期
Supplemental Prophylactic Intervention for Chemotherapy induced nausea and Emesis (SPICE-NZ) trial of the efficacy and safety of adjuvant ginger supplementation: A New Zealand randomized controlled feasibility trial.
niversity of Auckland0 个研究点目标入组 30 人开始时间: 2019年3月8日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Chemotherapy-naive (i.e. have not yet started chemotherapy) patients scheduled for chemotherapy classed as moderately or severely emetogenic
- •Aged >18 years.
- •Adequate physical function: baseline Karnofsky score > 60 (patient interview).
- •Females of child-bearing age entering this study must use an appropriate form of contraception. If a patient becomes pregnant during the course of this trial, they must notify the investigator as soon as possible.
排除标准
- •Patients scheduled for concurrent radiotherapy (medical note observation and/or discussion with treating oncologist).
- •Non-English speaking persons
- •People with severe cognitive impairment preventing their ability to fully understand the purpose of the study, adhere to the intervention and complete data collection forms. This will include diagnoses such as temporary delirium or dementia; but will be informed by the patients treating oncologist.
- •Pregnant or lactating women (medical note observation and confirmed via patent interview).
- •Concurrent use of other ginger-containing supplements and ingestion of large quantities of ginger (consumption of >1 ginger product > 4 days in the past week) (patient interview).
- •History of adverse reactions to ginger (patient interview).
- •Diagnosed with liver disease (medical note observation).
- •Experiencing nausea and vomiting for reasons other than chemotherapy (medical note observation and/or discussion with treating oncologist), including:
- •oPrescribed medications with nausea-related side-effects, e.g. newly-prescribed opioids,
- •oDiagnosed with malignancies that might cause nausea and vomiting due to the position of the cancer e.g. gastrointestinal cancer,
- •oMetabolic risk factors for nausea e.g. electrolyte imbalances
- •oMechanical risk factors for nausea e.g. intestinal obstruction
- •Chronic alcohol use as indicated by >14 standard drinks per week (predictive factor for decreased CIN risk)(29) (medical note observation and confirmed via patient interview).
- •Severe thrombocytopenia or likely to experience severe thrombocytopenia (platelets <50 x 10^9/L) (medical note observation).
- •Gallstones.
- •Currently prescribed warfarin, anti-coagulant therapy, hypoglycaemics, insulin, cyclosporine, tacrolimus, and nonsteroidal anti-inflammatory drugs (hypothesised interactions) (medical note observation).
- •Swallowing difficulties preventing supplement ingestion (medical note observation).
- •Self-prescribed nausea therapies or complementary products (patient interview).
- •Previously undergone chemotherapy treatment (medical note observation and/or discussion with treating oncologist).
- •Undergoing weekly or multi-day chemotherapy regiments (medical note observation and/or discussion with treating oncologist).
- •Patients found to be ineligible for temporary reasons (e.g. medication prescriptions, electrolyte imbalances or recent use of ginger) will be re-screened for eligibility prior to chemotherapy commencement.
研究者
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