Opioids for breathlessness in people with mesothelioma or asbestosis or other causes of interstitial lung disease.
A randomised, placebo-controlled, double-blind, cross-over study of the efficacy of sustained-release low dose morphine in the subjective sensation of dyspnoea as a result of maximally treated mesothelioma or asbestosis or other causes of interstitial lung disease in opioid naive participants.
Flinders University - Department of Palliative and Support Services
144 participants
Mar 18, 2011
Interventional
Conditions
Summary
This study aims to determine whether morphine reduces the feeling of breathlessness in patients with mesothelioma, asbestosis or interstitial lung disease. Who is it for? you can join this study if you are 18 years or more, and suffer from a feeling of breathlessness (dyspnoea) as a result of maximally treated mesothelioma, asbestosis, or interstitial lung disease. You must be able to speak English and should not be taking regular opioid medication (painkillers). Trial details Participants in this trial will be randomly (by chance) assigned to receive either 20mg sustained-release morphine (by oral capsule) together with a laxitive Coloxyl and Senna, or placebo (sham) tablets for one week. They will receive no medication for the second week and will then receive the alternate treatment ( morphine or placebo) for the third week. Participants will not know when they are taking the active drug or placebo. Participants will be asked to complete questionnaires and keep a diary over the 3 weeks of the trial to determine their response to treatment. They will also be phoned and visited at home by a nurse to monitor any side effects of treatment.
Eligibility
Inclusion Criteria1
- English speaking. Participants over the age of 18.Dyspnoea (3 or greater on the Medical Research Council scale) secondary to mesothelioma,asbestosis or any other cause of restrictive type pattern of interstitial lung disease. Renal function - calculated creatinine clearance >10mmol/l. Haemoglobin > 10 g/dl, or treating clinician has reviewed the haemoglobin result and confirmed that particpant does not need a blood transfusion. On stable oxygen - no changes to prescription in the last 3 days. On stable medications – no changes to prescription medications in the last 3 days. Able to complete participant diary.Willing and able to give informed consent.
Exclusion Criteria4
- Taking regular opioid medications.True adverse reaction(s) to morphine previously. Known hypersensitivity to any of the morphine sulphate capsule components. History of central hypoventilation syndrome.
- Use of monoamine oxidase inhibitor(s) (MAOIs) in the last 2 weeks or proposed use during the study. Australian Karnofsky Modified Performance Status (modified AKPS) < 50. Acutely confused (Nursing Delirium Assessment Scale score > 0 at baseline).Cognitive impairment (Mini-Mental State Examination < 24 at baseline). Uncontrolled nausea or vomiting.
- Gastrointestinal obstruction or documented peritoneal mesothelioma. Pregnancy, risk of pregnancy or breast feeding mothers.
- Past history of significant illicit opioid misuse.
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Interventions
One capsule of sustained- release Morphine 20mg taken orally, daily for 7 days, 1-2 tablets of Coloxyl and Senna taken orally, daily for the same 7 days, then a washout period of one week before crossing over to the placebo treatment . Tablets contain Docusate Sodium 50mg total sennosides (calculated as sennosideB) 8mg
Locations(3)
View Full Details on ANZCTR
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ACTRN12611000711910