A single arm, open label pilot study of low dose regular opioids with low dose regular benzodiazepines for the relief of refractory breathlessness.

Phase 3

Withdrawn

• Conditions: Refractory breathlessness; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12610000589088
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Adults (age>18)
Refractory dyspnoea where the underlying cause of the dyspnoea has been maximally treated.
A medical specialist must document that all identified reversible causes of the dyspnoea are being optimally managed
Breathlessness of a level 3 or higher on Modified Medical Research COuncil (MRC) dyspnoea scale
On stable medications over the prior week except as needed” medications
Prognosis of at least 2 months in the opinion of the treating clinician
English-speaking and able to read questionnaires

Exclusion Criteria

Allergic to clonazepam or to other benzodiazepines
Severe liver disease, key results greater than three times the upper limit of normal for the local laboratory
On regular opioid medications above the dose in the study (10 mg)
Anemia requiring transfusion
Confusion with a Folstein Mini-mental Status Exam <24/30.
Severely restricted performance status with Australian Modified Karnofsky Scale score of <50 at baseline
Uncontrolled nausea, vomiting and/or gastrointestinal obstruction.
Renal dysfunction with creatinine clearance calculated as less than 25 mls / minute.
Evidence of respiratory depression with resting respiratory rate less than 8 breaths per minute or a history of opioid induced respiratory depression.
Active respiratory or cardiac event in the previous week, not including upper respiratory tract infections.
Unable to give informed consent or complete diary entries.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure to inform the power calculations of a definitive study will be based on average breathlessness in the previous 12 hours (morning and evening) on the Visual Analogue Scale (VAS) score for breathlessness.[Day 5]

Secondary Outcome Measures

Name	Time	Method
Whether any perceived benefit is maintained over the study period given concerns about rapid tolerance to any of the beneficial effects of benzodiazepines using daily Visual Analogue scores for breathlessness, assessment of function using the dyspnoea exertion scale and a comparison of descriptors of breathless between baseline and exit.[Baseline, daily, and Day 5];Use of rescue medications such as apperients, other medications aimed at breathlessness control and oxygen. This will be recorded within the participant diary and the concurretn mediction sheet.[Day 5];Safety measures by National Cancer Institutes of Health Adverse Event Criteria daily, at exit and 4 week follow-up (weekly telephone call).[Daily, day 5, exit and weekly for four weeks];Global impression of change (5 point likert scale) and wish to continue to take the medication if available (Yes/no answer) using patient interview at exit.[Day 5]