A two-stage trial of response to antiemetic therapy in patients with cancer and nausea not related to anticancer therapy.Study 2: A randomised controlled double blind study of levomepromazine versus placebo with rescue antiemetics (best supportive care) in patients with refractory nausea

Professor Patsy Yates0 个研究点目标入组 272 人开始时间: 2010年6月11日最近更新: 2020年1月13日

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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); have refractory nausea despite adequate treatment (as defined below); are able to comply with all trial requirements; are able to provide fully informed consent.
•Refractory nausea is defined as: 1. nausea rated as greater than or equal to 3/10 on a NRS for average nausea after completion of study 1; or 2. nausea rated as greater than or equal to 3/10 at baseline despite the use of: appropriate antiemetics at sufficient dose (step 3) as specified in the study 1 targeted guideline category or haloperidol 3mg/24hrs or promethazine 25mg po tds (25mg sc 24 hrly) or metoclopramide 60mg/24hrs or domperidone 20mg qid or cyclizine 100mg/24hrs (75mg/24hrs in the elderly) or ondansetron 8mg/day or 3. nausea rated as greater than or equal to 3/10 at baseline if appropriate antiemetics, or any of those listed above, have not been tolerated because of side-effects.
•If patients have been on antiemetic combinations, at least one of the agents must have been given at doses as specified above.

•Patients who: have nausea related to the treatment of cancer (i.e. surgery, chemotherapy, radiotherapy) - within 5 days of anticancer therapy; have nausea for which a specific antiemetic is indicated and randomisation to study medications or placebo 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 the study or are likely to undergo a procedure or intervention with the potential to affect nausea during the 3 day study period; have received levomepromazine within the last 3 days; if on corticosteroids, the dose has changed within 48 hours prior to study; have a definite contraindication to levomepromazine (e.g. severe hepatic impairment (LFTs > 5 x upper limit of normal (this applies to AST, ALT or bilirubin but not to ALP or GGT measurements)), symptomatic postural hypotension); have had a previous adverse reaction to the study medication; are pregnant or breastfeeding; have participated in a trial of a new clinical entity within the last 28 days

发起方

Professor Patsy Yates