Palliative Care Clinical Studies Collaborative (PaCCSC) - Collected Works
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Browsing Palliative Care Clinical Studies Collaborative (PaCCSC) - Collected Works by Author "Allcroft, Peter"
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ItemOnce-daily opioids for chronic dyspnea: a dose increment and pharmacovigilance study(Elsevier, 2011-04-04) Currow, David Christopher ; McDonald, Christine ; Oaten, Sheila ; Kenny, Bernadette ; Allcroft, Peter ; Frith, Peter Anthony ; Briffa, Michael ; Johnson, Miriam J ; Abernethy, Amy PickarContext Randomised controlled trials (RCTs) can answer questions of efficacy, but rarely generate a complete safety profile. Long term pharmacovigilance studies complement RCTs. Objectives Level I evidence supports short term efficacy of opioids in reducing refractory dyspnoea. This study aims to determine: the minimum effective daily dose of sustained release morphine to reduce refractory breathlessness; and whether net clinical benefits are sustained safely. Methods In a phase II dose increment study, 10mg sustained release morphine was administered daily, and increased by 10mg daily each week to a maximum of 30mg daily. The participant was withdrawn if there were unacceptable side-effects or no response to maximum dose. If participants had a 10% improvement in dyspnoea over their own baseline, they joined a long-term phase IV effectiveness/safety study at that dose. Complying with STROBE guidelines for reporting observational studies, response and side-effects are described, with demographic and clinical characteristics of responders. Results Eighty five participants (65 males, mean age 74, 59% with chronic obstructive pulmonary disease (COPD) provided >30 patient-years of data. Fifty three participants derived ≥10% benefit (35.4% improvement over baseline) giving a response rate of 62% (number needed to treat of 1.6); for 70%, this dose was 10mg/24hours. Benefit was maintained at three months for 28 (33%) people. Breathlessness was reduced significantly (p<0.001) but constipation increased (p<0.001) despite aperients. There were no severe adverse events including no respiratory depression nor hospitalisations. Conclusion Ten mg of sustained release oral morphine daily is safe in this population, and effective for most people.
ItemThe role of benzodiazepines in breathlessness: a single site, open label pilot of sustained release morphine together with clonazepam(Mary Ann Liebert, Inc., 2013-04-18) Allcroft, Peter ; Margitanovic, Vera ; Greene, Aine ; Agar, Meera Ruth ; Clark, Katherine ; Abernethy, Amy Pickar ; Currow, David ChristopherBackground: Breathlessness at rest or on minimal exertion despite optimal treatment of underlying cause(s) is distressing and prevalent. Opioids can reduce the intensity of chronic refractory breathlessness and an anxiolytic may be of benefit. This pilot aimed to determine the safety and feasibility of conducting a phase III study on the intensity of breathlessness by adding regular benzodiazepine to low-dose opioid. Methods: This is a single site, open label phase II study of the addition of regular clonazepam 0.5 mg nocte orally to KapanolR 10 mg (sustained release morphine sulphate) orally mane together with docusate/sennosides in people with modified Medical Research Council Scale ≥2. Breathlessness intensity on day four was the efficacy outcome. Participants could extend for another 10 days if they achieved >15% reduction over their own baseline breathlessness intensity. Results: Eleven people had trial medication (eight males, median age 78 years (68 to 89); all had COPD; median Karnofsky 70 (50 to 80); six were on long-term home oxygen. Ten people completed day four. One person withdrew because of unsteadiness on day four. Five participants reached the 15% reduction, but only three went on to the extension study, all completing without toxicity. Conclusion: This study was safe, feasible and there appears to be a group who derive benefits comparable to titrated opioids. Given the widespread use of benzodiazepines for the symptomatic treatment of chronic refractory breathlessness and its poor evidence base, there is justification for a definitive phase III study.