TerminatedPhase 3ACTRN12611000711910

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.


Sponsor

Flinders University - Department of Palliative and Support Services

Enrollment

144 participants

Start Date

Mar 18, 2011

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether low-dose opioid medication (morphine) can reduce severe breathlessness in adults with mesothelioma, asbestosis, or other interstitial lung diseases. Participants must be 18 or older with significant breathing difficulty and not currently taking regular opioids. The trial aims to determine if opioids can safely and effectively ease chronic breathlessness in these conditions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 cross

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)

Royal Melbourne Hospital - City campus - Parkville

NSW,SA,VIC, Australia

Flinders Medical Centre - Bedford Park

NSW,SA,VIC, Australia

Westmead Hospital - Westmead

NSW,SA,VIC, Australia

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ACTRN12611000711910