A double blind randomised controlled trial examining the effect of intravenous zoledronic acid on pleural fluid production, breathlessness and quality of life in patients with a malignant pleural effusion

orth Bristol NHS Trust (UK)0 个研究点目标入组 30 人开始时间: 2011年9月29日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Malignant pleural thickening with or without pleural effusion with
•1.1. Malignant fluid cytology or
•1.2. Malignant pleural biopsy histology or
•1.3. In the context of clinically proven cancer elsewhere with no alternative cause found for the pleural thickening or effusion
•2. Age > 18 years; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified

•1. Chemical or surgical pleurodesis in the preceding 30 days
•2. Intravenous (IV) bisphosphonate within the past 3 months or ongoing therapy
•3. Ongoing dental disease requiring intervention
•4. Significant renal failure (calculated creatinine clearance of < 40ml/min)
•5. Hypocalcaemia at randomisation
•6. Inability to give informed consent
•7. Pregnancy or lactation
•8. Known allergy to bisphosphonates or exipients in the intervention preparation
•9. Life expectancy < 4 months
•10. Current or planned chemotherapy (However patients receiving the oral chemotherapy agent, tarceva who have been on it for more than 3 months can be included)
•11. Hormone manipulation therapy initiated in the month before trial entry (however patients receiving long term hormone manipulation can be included)
•12. Haematological malignancy
•13. Age < 18 years (no upper age limit)
•14/. Severe visual impairment.

发起方

orth Bristol NHS Trust (UK)