A two-stage trial of response to antiemetic therapy in patients with cancer and nausea not related to anticancer therapy. Study 1: A randomised open label study of guideline driven targeted antiemetic therapy versus single agent antiemetic therapy.

Professor Patsy Yates0 个研究点目标入组 216 人开始时间: 2010年6月11日最近更新: 2020年1月13日

适应症

试验速览

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•Patients who: are 18 years or over, have a clinical diagnosis of cancer, have nausea with an average score over the last 24 hours of greater than or equal to 3 on an 11 point numerical rating scale (NRS) anchored at 0 (no nausea) and 10 (worst possible nausea), are not currently receiving antiemetics or are already receiving antiemetics but these are inappropriate as defined by the antiemetic guidelines or are at a suboptimal dose, are able to comply with all trial requirements, are able to provide fully informed consent

•Patients who: have nausea related to the treatment of cancer (i.e. surgery, chemotherapy, radiotherapy) where acute treatment with 5HT3 antagonists is indicated (i.e. within 5 days of anticancer therapy), have nausea for which a specific antiemetic is indicated and randomisation to haloperidol would not be appropriate (e.g. dexamethasone for acutely raised ICP), have undergone a procedure or intervention with the potential to affect nausea within 2 days prior to study or are likely to undergo a procedure or intervention with the potential to affect nausea during the 3 day study period, if on corticosteroids, the dose has changed within 48 hours prior to study, have a definite contraindication to any of the drugs listed in the guidelines (e.g. Parkinson’s disease, QTc prolongation on most recent ECG (>450msecs in men, >470msecs in women), uncontrolled seizures), have had a prior serious adverse event following use of any of the drugs listed in the guidelines (e.g. dystonic reaction, neuroleptic malignant syndrome), are pregnant or breastfeeding

发起方

Professor Patsy Yates