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Bristol Randomised Trial Of Zoledronic Acid in Malignant Pleural Effusions (pilot study)

Bristol Randomised Trial Of Zoledronic Acid in Malignant Pleural Effusions (pilot study). A double blind randomised controlled trial examining the effect of intravenous zoledronic acid on pleural tumour progression, pleural fluid production, breathlessness and quality of life in patients with malignant pleural disease.

Aim of study

This pilot study seeks to inform a large multicentre randomised controlled trial examining the effect of zoledronic acid on pleural tumour progression, pleural fluid production, breathlessness and quality of life in patients with malignant pleural disease as compared to placebo in patients with symptomatic malignant pleural effusions of all histological types

Design

Double blind randomised controlled trial of 30 patients from the North Bristol Lung Centre

Outcome measures

Primary outcome

  • Change in gadolinium uptake and washout rate on DCE-MRI
  • Change in dyspnoea VAS score

Secondary outcomes

  • Disease progression as measured by volume of pleural thickening on CT scan
  • Disease progression as measured by volume of pleural thickening on DCE-MRI scan
  • For patients with a pleurx catheter in situ, change in fluid volume production between week 2 of run in period and each week post intervention or placebo
  • For patients with pleurx catheter in situ, spontaneous pleurodesis rate
  • Change in pleural fluid and plasma VEGF-A between baseline and each aspiration following intervention or placebo (with correlation to fluid drainage in pleurx patients)
  • Change in volume of pleural fluid on CT

Contact

Clare Hooper
Email: clarehooper@doctors.org.uk

Inclusion criteria

  • Malignant pleural thickening with or without pleural effusion with a. malignant fluid cytology or b. malignant pleural biopsy histology.
  • Age >18 years

Exclusion criteria

  • Chemical or surgical pleurodesis in the preceding 30 days
  • IV bisphosphonate within the past 3 months or ongoing therapy
  • Ongoing dental disease requiring intervention
  • Significant renal failure (calculated creatinine clearance of <50ml/min)
  • Hypocalcaemia at randomisation
  • Inability to give informed consent
  • Pregnancy or lactation
  • Known allergy to bisphosphonates or exipients in the intervention preparation
  • Life expectancy <4 months
  • Current or planned chemotherapy
  • Hormone manipulation therapy initiated in the month before trial entry (however patients receiving long term hormone manipulation can be included)
  • Haematological malignancy
  • Age <18 years (no upper age limit)
  • Severe visual impairment

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