Palliative Care Clinical Studies Collaborative (PaCCSC)

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https://hdl.handle.net/2328/26917

The Palliative Care Clinical Studies Collaborative was established to build the evidence base for palliative medications that can improve practice, and to expend clinical trials research capacity in the area of palliative care.

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Current approaches to diagnosing and managing constipation in advanced cancer and palliative care
(Mary Ann Liebert, Inc., 2010-04-12) Clark, Katherine; Urban, Kat; Currow, David Christopher
Constipation is common in advanced cancer. Despite this, clinicians' understanding of the underlying changes affecting the colon and the rest of the gastrointestinal tract are limited. Two case histories are used to illustrate the problems encountered when the current approaches to diagnosing and managing altered bowel habits are unsuccessful. An alternative paradigm in which to consider the problems of constipation encountered by some people with advanced cancer is proposed.
How should we conduct and interpret phase III clinical trials in palliative care?
(Elsevier, 2010-01) Abernethy, Amy Pickar; Clark, Katherine; Currow, David Christopher
The article by Wildiers et al.1 raises some challenges in terms of ethical approaches to phase III end-of-life studies and their interpretation. Although the authors should be commended for undertaking a large, multisite, randomized, controlled trial in palliative care, there are fundamental questions that do need to be addressed before the first steps can be taken to adopt the study's findings into practice.
Letter to the Editor re "Four essential drugs needed for quality care of the dying: a Delphi-study based international expert consensus opinion"
(Mary Ann Liebert, Inc., 2013-06-21) Clark, Katherine; Sheehan, Caitlin; Currow, David Christopher
High-quality patient care can be defined as an approach that minimizes harm whilst aligning with people's expectations. Dying people and their relatives have articulated that they expect health care providers to manage physical and psychological symptoms well, with expectations even higher when such care is delivered by specialist services. Despite excellent intentions, palliative care clinicians and researchers have done little to improve systematically the evidence base for prescribing when people are actually dying. Few data exist to inform clinicians' understanding of how people's actual experiences align with their articulated wishes. Symptoms are managed based on relatives' and staff's assumptions of the experience of the dying person, with a “good death” often being seen as quiet and calm. Achieving this often requires sedation, for which the dying person will very rarely have given consent. This requires consideration, especially when evidence suggests people facing death will forgo symptom control to remain as alert and interactive for as long as possible. We ignore patients' wishes at our peril if we are to be truly patient centered.
Pharmacovigilance in hospice/palliative care: rapid report of net clinical effect of metoclopramide
((C) Mary Ann Liebert, Inc., 2012-07-20) Currow, David Christopher; Vella-Brincat, Jane; Fazekas, Belinda Susan; Clark, Katherine; Doogue, Matthew; Rowett, Debra Sharon
Background: Understanding the performance of prescribed medications in day-to-day practice is important to minimize harm, maximize clinical benefits, and, eventually, better target the people who are most likely to benefit, especially in hospice/palliative care where there may be limited time to optimize prescribing. Metoclopramide, a benzamide prokinetic antiemetic, is widely used for a number of indications including nausea, vomiting, hiccups, and reflux. It has recently had a new ‘‘black box’’ warning issued by the Food and Drug Administration in relation to tardive dyskinesia to limit use to 12 weeks. Methods: A consecutive cohort of patients from 12 participating centers in two countries who were having metoclopramide initiated had data collected at three time points—baseline, 2 days (clinical benefit), and day 7 (clinical harm). Additionally, harms could be recorded at any time. Results: Of the 53 people included in the cohort, 23 (43%) reported benefit at 48 hours, but only 18 (34%) of these people were still using it one week after commencing it. For the other 5, the medication was ceased due to harms. The most frequent harms were akathisia (n = 4), headache (n = 4), and abdominal pain (n = 4). Nine people (17%) had no clinical benefit and experienced harms. Conclusion: Overall, one in three people gained net clinical benefit at one week. Limiting effects include sideeffects that need to be sought actively in clinical care.
A pilot study to assess the feasibility of measuring the prevalence of slow colon transit or evacuation disorder in palliative care
(Mary Ann Liebert, Inc., 2013-04-27) Clark, Katherine; Currow, David Christopher
Context: Constipation is prevalent in palliative care. Whilst numerous factors contribute to this problem, opioid analgesia remains the most quoted aetiology. However, in gastroenterology, constipation is classified as a problem of prolonged transit times of colonic contents, impaired function of the structures of defecation or both. Little work in palliative care has used these assessments. Aims: The report aims to describe the feasibility of assessing the colon transit times and pelvic floor structures of constipated palliative care patients and to report the results of a pilot study of 10 people who underwent these investigations. Methods: Colon transit times were measured with a combination of orally administered radio-opaque markers and a single plain radiograph of the abdomen at day 5. Anal manometry plus rectal balloon expulsion was used to assess the pelvic floor. The results of the investigations were used to allocate people to one of four constipation subcategories: 1). slow colonic transit; 2) evacuation disorders; 3) mixed disorder or 4) normal transit. Results: Two people had slow transit only, 2 people had evacuation disorders only and 5 had both. Only person had neither problem. The investigations were well tolerated and took a small amount of people's time. Conclusion: These pilot data strongly support the feasibility of undertaking comprehensive assessments of the colon and pelvic floor in palliative care patients with the results, although preliminary, highlighting the complexity of the problem of constipation. The results of this work underpin the need to progress to a much larger study.
The 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 Christopher
Background: 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.
The role of ondansetron in the management of cholestatic or uremic pruritis - a systematic review
(2012-11) To, Timothy H M; Clark, Katherine; Lam, Lawrence; Shelby-James, Tania Maree; Currow, David Christopher
Pruritus associated with hepatic or renal failure can be a troublesome symptom, refractory to treatment, associated with significant physical and emotional distress, and reduction in quality of life for patients already burdened with chronic disease. Serotonin has been implicated as a possible pathological mediator, and therefore 5HT3 antagonists have been suggested as a possible therapeutic intervention. Objectives This review of the literature systematically explores the role of ondansetron in the management of cholestatic or uraemic pruritus. Methods Electronic databases were systematically searched for randomized controlled trials (RCTs) examining the role of ondansetron in cholestatic or uraemic pruritus between 1966 and 2008. Results Five RCTs were included in this systematic review: three for cholestatic pruritus, and two for uraemic pruritus. All trials examined ondansetron versus placebo, however with differing treatment protocols. Overall, three studies showed no benefit to ondansetron over placebo, however two studies in cholestatic pruritus showed small reductions in pruritus with questionable clinical significance. Conclusion Ondansetron was demonstrated to have negligible effect on cholestatic or uraemic pruritus on the basis of a limited number of studies.

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