Examining the effect of intravenous zoledronic acid on pleural fluid production, breathlessness and quality of life in patients with a malignant pleural effusio

Phase 4

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Lung (small cell), Lung (non-small cell); Cancer; Malignant pleural effusion

• Registration Number: ISRCTN17030426
• Lead Sponsor: orth Bristol NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-29
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified