Assessment of normal release morphine in the management of dyspnoea
Phase 1
- Conditions
- Breathlessness of any cause in cancer patients are identified and treated with normal release morphine which has been shown to be both effective and safe.The idea of the trial is to see if there will be an added benefit to gentle dose increments. There are no placebos used.
- Registration Number
- EUCTR2004-004620-12-GB
- Lead Sponsor
- Royal Marsden Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
?A score of equal or more than 3 on the Modified Borg scale at rest
?Cancer diagnosis
?Inpatient at The Royal Marsden Hospital
?Aged over 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
?A score for breathlessness of less than 3 on the Modified Borg scale at rest
?Non cancer diagnosis
?Cognitive impairment
?Planned therapeutic procedure / anticancer treatment for breathlessness during the trial time.
?Patients taking opioids for moderate to severe pain e.g morphine, fentanyl, oxycodone.
?Aged under 18 years
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of this study is to investigate the effect of dose titration of morphine on patients who are dyspnoeic.<br>Primary objective:<br>To determine if a titrated increase in normal release morphine leads to a corresponding improvement in dyspnoea<br><br>;Secondary Objective: •To determine if there is a ceiling effect to the benefits of morphine on dyspnoea<br>•To see if patients tolerate titration of morphine for dyspnoea.<br>•To see if patients anxiety levels decrease if dyspnoea improves<br>;Primary end point(s): to identify the dose that best treats the symptoms of shortness of breath
- Secondary Outcome Measures
Name Time Method