PaCCSC clinical trials

Open clinical trials

PaCCSC conducts clinical trials that contribute to improved quality of life for people living with life-limiting illness. Click on the links below to find our about our current clinical trials.

The ITCC Clinical trials page includes frequently asked questions about clinical trials. Consumer, health professional and researcher queries may be directed to itcc@uts.edu.au.

BETTER-B (AUS)

Smiling senior father and adult son on a walk

Investigators

The Chief Investigator (Australia) for this study is Professor David Currow.

The site principal investigators are Professor John Wheatley, Westmead Hospital, Dr Megan Ritchie, Concord Hospital, Dr Caitlin Sheehan, Calvary Health Care, Dr Peter Eastman, Barwon Health, McKellar Centre and Dr Michael Epton, Christchurch Hospital, New Zealand.

Health condition

Breathlessness

Full study title

BETTER-B (AUS) - BETter TreatmEnts for ChRonic Breathlessness (Australia)

An international, multicentre, randomised controlled pragmatic trial of mirtazapine to alleviate breathlessness in palliative and end of life care (Australian arm).

Aims

To find out if mirtazapine, an antidepressant, helps with breathlessness in people living with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).

To find out from close friends or relatives of the people who agree to take part in this study, if they think taking mirtazapine helps with breathlessness.

Summary

Breathlessness is a common, distressing symptom in advanced diseases, particularly those affecting the heart and lungs, causing considerable disability for patients, an anxiety and social isolation for them and their family and carers.

Breathlessness that continues, despite optimal management of the underlying causes and current symptom relief measures, is termed 'chronic'. It generally worsens as disease progresses and is one of the most frightening aspects facing a person with advanced disease.

Breathlessness is associated with shortened life expectancy and often results in emergency visits and hospitalisation.

Non-pharmacological treatments take priority for chronic breathlessness, especially when patients are able to participate in physiotherapy, and where possible are first line treatment. However, there are few effective pharmacological treatments thus, chronic breathlessness represents a huge unmet need and new approaches are desperately required. Preliminary data suggest that serotonergic modulations may be beneficial but rigorous evaluation has not been conducted. There is therefore a need to explore the potential role of antidepressants in this setting.

Mirtazapine is widely used noradrenergic and specific serotonergic antidepressant (NaSSA). There is clinical experience to support its use in anxiety and panic disorder and clinical evidence for its use in major depressive disorders associated with anxiety.

BETTER-B will help address this unmet need by determining whether mirtazapine has a role in the management of chronic breathlessness in patients with chronic obstructive pulmonary diseases (COPD) and interstitial lung disease (ILD).

Participating sites

The participating sites for the Australian arm of this study are:

Westmead Hospital
Concord Hospital
Calvary Health Care
Barwon Health, McKellar Centre

Funding

BETTER-B (AUS) has received funding from the National health and Medical Research Council (NHMRC).

Life-space assessment-palliative care (LSA-PC)

Investigators

The principal investigator is Professor Jane Phillips.

The investigation team includes Professor Lawrence Lam, Dr Tim Luckett, Professor Meera Agar and Professor David Currow

Full study title

Validation of Modified Life-Space Assessment for palliative care populations

Aim

To assess if the Life-Space Assessment can accurately capture the degree to which people with palliative care needs who are living at home move freely and interact within their own home and their local community.

Summary

Maintaining independence for as long as possible by careful symptom control is a key palliative care goal. The extent to which palliative care intervention enable people to continue and maintain daily life within their environment of choice id difficult to measure comprehensively because of the physical, emotional, spiritual, occupational and social functioning domains impacting on a person's interaction within their life space.

People receiving palliative care are often too unwell to burden with an extensive battery of self-report measures. The expanded Life-Space Assessment questionnaire, which measures the spatial extent of the person's typical excursion over a defined period, if it is sensitive to changes over a short time frame may have applicability in palliative care populations as a brief summary measure of capacity to maintain functionality and engage in everyday activities of living.

Eligibility

This study is open to patients who live in the community (not hospitalised) and who are visited by a community-based palliative care service.

Participating sites

Sacred Heart Health Service
Calvary Kogarah
Concord Hospital
Barwon Health Service

Funding

Palliative Care Clinical Studies Collaborative (PaCCSC)

The UP study

Investigators

The Principal Investigator for this study is Dr Raj Aggarwal.

The investigation team includes Professor Meera Agar and Dr Thang Du Huynh.

Full study title

A multi-centred pilot study phase 2 prospective, randomised, placebo-controlled trial to determine the efficacy, side effects profile and optimal dose of Pregabalin in the management of uraemic pruritus in patients with End Stage Kidney Disease (ESKD) who are conservatively managed.

ANZCTR trial ID

tbc

Aim

The aim of this study is to determine the efficacy, side effects and optimal dose of Pregabalin in the management of uraemic pruritus in people wtih End SStage Kidney Disease (ESKD).

Summary

Uraemic pruritus (UP) is a common and often disabling symptom experienced by people with ESKD. It is associated with an impaired quality of life, disrupted sleep, depression and reduced mortality. In a large systematic study of symptom prevalence in people with ESKD on dialysis, the mean weighted prevalence of UP was 55% and in studies of symptom prevalence in people with ESKD being managed conservatively the prevalence ranged from 69% to 74%.

While there are many theories, the aetiology of UP remains uncertain. Among those medications that have shown encouraging results in the treatment of UP are alpha 2 delta subunit ligands (gabapentinoids). A recent qualitative systematic review of the literature on the management of UP with gabapentin indicates more high-quality research is needed.

Eligibility

Pruritus, or itch, is a common problem for people with chronic renal failure. You may be eligible to participate in this trial if you are 18 years or older and have moderate to severe itch or chronic itch.

Participating sites

Liverpool Hospital
Other sites tba

Funding

Palliative Care Clinical Studies Collaborative

Closed clinical trials

We welcome your interest and enquiries about past trials' outcomes. Enquire about these trials by email to itcc@uts.edu.au.

Breathlessness Exertion and Morphine Sulphate Study (BEAMS)

Investigators

The principal investigator is Professor David Currow.

The Chief Investigators for this study are Dr Magnus Ekstrom, Professor Miriam Johnson, Professor Christine McDonald, Professor John Miners, Professor Carl Kirkpatrick, Professor Andrew Somogyi, Professor Linda Denehy, Dr Nikki McCaffrey and Associate Professor Danny J. Eckert.

The Associate Investigators are Professor Lawrence Lam, Aine Greene, Belinda Fazekas, Dr Brian Le, Professor Katherine Clark, Professor Kwun Fong, Professor Meera Agar, Dr Rohit Joshi, Professor Sharon Kilbreath, Dr Diana Ferreira, Professor Angela Clow, Dr Nina Smith, Dr Richella Ryan and Dr Sara Booth.

Health condition

Chronic obstructive pulmonary disease, breathlessness

Full study title

A pragmatic, phase III, multi-site, double-blind, placebo-controlled, parallel-arm, dose-increment, randomised trial of regular, low-dose extended-release morphine for chronic refractory breathlessness.

Trial ID

NCT02720822

Aim

To determine if small regular doses of morphine can enable better management of symptoms and activity in people with chronic obstructive pulmonary disease (COPD).

Summary

Breathlessness is an overwhelming symptom affecting tens of thousand of Australians every day. For many people, it persists even when all the underlying causes have been optimally managed (chronic breathlessness). In these circumstance, it often occurs at rest or with minimal exertion.

Evidence from a number of clinical studies suggests that a small, regular dose of morphine helps to reduce safely the sensation of breathlessness. However, it is not well established which patients derive more benefits and what is the net clinical effect of this treatment (weighing benefits and harms).

Eligibility

Participants in this study were 18 years of age or older and have a diagnosis of COPD.

Participating sites

Concord Hospital, Concord
St Vincent's Hospital Sydney - Sacred Heart Hospice, Darlinghurst
Calvary Health Care Kogarah, Kogarah
Liverpool Hospital, Liverpool
Prince Charles Hospital, Brisbane
Nambour Hospital, Sunshine Coast
Flinders Medical Centre, Adelaide
St Vincent's Hospital, Melbourne
Barwon Health, Geelong
The Austin Hospital, Heidelberg
The Royal Melbourne Hospital, Melbourne
Sir Charles Gairdner Hospital, Perth
Clare Holland House, Calvary Public Hospital, Canberra
Westmead Hospital, Westmead

Funding

This study was been funded with a grant from the National Health and Medical Research Council (NHMRC).

Management of constipation in palliative care

Investigators

The Principal Investigator for this study was Associate Professor Katherine Clark.

The investigation team included Professor David Currow, Professor Nicholas Talley, Dr Phillip Dinning, Professor Lawrence Lam, Professor Patricia Davidson, Professor Meera Agar, Professor Jane Phillips, Tania Shelby-James and Nikki McCaffrey.

Health condition

Constipation in palliative care

Full study title

Can less be better? Is it possible to improve constipation symptom control in palliative care patients when they underlying causes of bowel dysfunction are objectively assessed?

ANZCTR Trial ID

ACTRN12611000705987 (opens external site)

Summary

Constipation is a common, distressing and serious symptom, affecting 50 to 90% of people referred to specialist palliative care services, with 40 to 70% of failing to achieve adequate symptom control. The number of people failing to achieve satisfactory symptom relief is not acceptable as inadequate symptom relief is responsible for adding to individual and societal burdens.

In palliative care, decisions regarding the prescription of laxatives are based predominately on clinical experience and institutional approaches. Many of these do not consider the pathophysiological basis that underlies the symptom of constipation. This approach is dissimilar to that adapted by gastroenterologists in the treatment of non-palliative care patients. The most striking difference is the limited information to categorise the palliative population into the groupings that gastroenterologists would routinely use, thereby limiting the ability to tailor intervention to improve symptom control.

Aim

This study aimed to:

develop an approach to constipation that enables the underlying problems (slow transit of colonic contents, delayed outlet of colonic contents or an overlap of these problems), to be quantified in palliative care patients using well-tolerated and validated diagnostic methods
compare whether the constipation severity of those patients randomly allocated to a mechanistic approach to the assessment and treatment of constipation within different sub-categories have better patient outcomes than people palliated using standard current clinical care.

Funding

National Health and Medical Research Council
Palliative Care Clinical Studies Collaborative

Morphine or placebo (MOP)

Investigators

The Principal Investigator for this trial was Professor David Currow.

The investigation team included Professor Christine McDonald, Dr John Plummer, Associate Professor Amy Abernethy, Dr Hope Uronis, Professor Trish Davidson, Professor Peter Frith, Professor Meera Agar, Associate Professor Simon Eckermann, Dr Matt Doogue and Professor Katherine Clark.

Publications

Currow, D., Louw, S., McCloud, P., Gazekas, B., Plummer, J., McDonald, C.F., Agar, M., Clark, K., McCaffrey, N., Ekström, M. Regular, sustained-release morphine for chronic breathlessness: a multicentre, double-blind, randomsed, placebo-controlled trial. Thorax Published Online First: September 2019. doi: 10.1136/thoraxjnl-2019-213681

Ferreira, D.H., Louw, S., McCloud, P., Fazekas, B., McDonald, C.F., Agar, M., Clark, K., McCaffrey, N., Ekström, M., Currow, D.C. Controlled-release oxycodone versus placebo in the treatment of chronic breathlessness - a multi-site randomised placebo controlled trial. Journal of Pain and Symptom Management Published online October 2019. doi: 10.1016/j.painsymman.2019.10.017

Health condition

Refractory breathlessness

Full study title

A randomised double-blind, multi-site, parallel arm controlled trial to assess relief of breathlessness comparing fixed doses of morphine and placebo in people with refractory breathlessness.

ANZCTR Trial ID

ACTRN12609000806268 (opens external site)

Aim

Primary objectives

To compare the efficacy of opioids (sustained release morphine) with placebo to compare the efficacy for relieving the sensation of breathlessness, level of function, safety and quality of life for participants with refractory breathlessness.

To identify clinical and pharmacogenomic parameters that predict who would achieve the greatest benefit from the intervention and establish a blinded participant preference.

Secondary objectives

To focus on the impact of the intervention on improving quality of life, adverse effects, function, use of breakthrough opioids and clinical predictors of benefit.

Summary

Breathlessness is a major clinical problem for many people with advanced progressive illnesses. These illnesses include chronic obstructive pulmonary disease, end-stage cardiac failure and cancer.

Previous studies supported the use of morphine for chronic breathlessness. This phase III study was seeking to provide further data to determine that morphine was a well-tolerated and effective intervention for a broad range of people with refractory breathlessness.

This study sought to establish that the net benefit outweighed any toxicity encountered and ease the concerns of many clinicians that there was a risk that opioids may cause respiratory depression.

Funding

Commonwealth Department of Health and Ageing

Pyridostigmine for constipation

Investigators

The Principal Investigator for this study was Professor Katherine Clark.

The investigation team included Professor David Currow, Professor Nicholas Talley, Ms Naomi Byfieldt, Professor Lawrence Lam, Ms Debra Rowett, Professor Meera Agar, Dr Steve Quinn, Ms Nikki McCaffrey, Ms Linda Brown and Ms Belinda Fazekas.

Health condition

Constipation, palliative care

Full study title

A pilot study to explore the safety of pyridostigmine in constipated palliative care patients.

ANZCTR Trial ID

ACTRN12614000540617 (opens external site)

Aim

The primary aims of this pilot study were to examine if it was safe to conduct a phase III study of pyridostigmine.

Summary

Constipation is a common, distressing and serious problem affecting 50-90% of people referred to specialist palliative care services. Approximately half of these people do not achieve adequate management of their constipation. The number of people who do not achieve satisfactory relief is not acceptable. The researchers conducting this study were looking to see if there were more effective ways to treat constipation.

Participating sites

Braeside Hospital
Calvary Mater Newcastle
Liverpool Hospital
St Vincent's Hospital Darlinghurst

Funding

Calvary Mater Hospital
Palliative Care Clinical Studies Collaborative (PaCCSC)

Outcomes

The study was closed after three years due to slow recruitment.

Risperidone and haloperidol in delirium

Investigators

The Principal Investigator for this study was Professor Meera Agar.

The investigation team included Associate Professor Brian Draper, Associate Professor Gideon Caplan, Dr Mark Hill, Ms Tania Shelby-James, Ms Debra Rowett, Professor David Currow, Associate Professor Peter Lawlor, Dr Chris Sanderson, Dr John Plummer, Associate Professor Simon Eckermann and Dr Steve Quinn.

Outcomes

PaCCSC is pleased to report that this is the first definitive trial of treatment for delirium symptoms. Our findings support the recommendations in the recently released Delirium Clinical Standards from the Australian Commission for Safety in Quality Health Care, and place even further caution on the use of antipsychotics for delirium therapy.

The findings of this study are important as they demonstrate that there is no safe or effective medication to treat delirium, and that off-label prescribing is not beneficial for patients, ultimately leading to inadequate symptom management. Moreover, the results of this study have confirmed the need to continue undertaking properly-designed, adequately-powered clinical trials in palliative care.

Publications

Agar, M., Lawlor, P.G., Quinn, S., Draper, B., Caplan, G.A., Rowett, D., Sanderson, C., Hardy, J., Le, B., Eckermann, S., McCaffrey, N., Devilee, L., Fazekas, B., Hill, M., Currow, D.C. Efficacy of Oral Risperidone, Haloperidol, or Placebo for Symptoms of Delirium Among Patients in Palliative Care: A Randmomized Clinical Trial. JAMA Intern Med. 2017;177(1):34-42. doi: 10.1001/jamainternmed.2016.7491

Health condition

Delirium

Full study title

Oral risperidone, oral haloperidol, and oral placebo in the management of delirium in palliative care.

ANZCTR Trial ID

ACTRN12607000562471 (opens external site)

Aim

To determine the efficacy of the medication to control delirium symptoms.

Summary

Delirium is prevalent in patients with advanced cancer and in the palliative care setting and is associated with significant and distressing symptomology and poor prognosis. Antipsychotics are considered by most clinicians as first line pharmacotherapeutic agents for delirium despite limited randomised double-blind controlled evidence for management of delirium in any health care setting, including palliative care.

The few studies that existed prior to this study explored post-treatment efficacy in relation to total delirium score reduction and did not guide management of target symptomology. There had been no systematic evaluation of toxicity profile in relation to delirium management with typical or atypical antipsychotics, in particular extrapyramidal toxicity and degree of sedation. There was a need for randomised control trial evidence of the efficacy of antipsychotics to control targeted delirium symptoms, and also to consider broader implications on caregiver and patient distress.

Participating sites

Barwon Health, Geelong
Braeside Hospital
Calvary Health Care Kogarah
Calvary Mater Newcastle
Repatriation General Hospital
Sacred Heart Hospice, St Vincent's Hospital
The Royal Melbourne Hospital

Funding

Commonwealth Department of Health and Ageing

Sertraline for breathlessness

Investigators

The Principal Investigator for this study was Professor David Currow.

The investigation team included Dr John Plummer, Associate Professor Amy Abernethy, Professor Patricia Davidson, Professor Meera Agar, Professor Simon Eckermann, Dr Matt Doogue and Associate Professor Katherine Clark.

Outcomes

The primary results of this study demonstrated that breathlessness intensity lessened in both arms of the study with no difference between groups in the primary outcome.

Secondary outcomes who there was no difference observed between groups in the proportion of participants who had a more than 15% change from baseline in any measure of breathlessness.

There was no net benefit observed for sertraline on chronic breathlessness in participants who had undergone optimal treatment of the underlying causes in this trial.

The current findings do not support he use of sertraline for the symptomatic treatment for chronic breathlessness, nor did the study identify any sub-groups more likely to respond that could form the basis of further studies.

Publications

Currow, D.C., Ekström, M., Louw, S., Hill, J., Fazekas, B., Clark, K., Davidson, P.M., McDonald, C., Sajkov, D., McCaffrey, N., Doogue, M., Abernethy, A.P., Agar, M. (2018). Sertraline in symptomatic chronic breathlessness: a double blind, randomised trial. European Respiratory Journal 2019, 53(1); doi: 10.1183/13993003.01270-2018

Health condition

Chronic breathlessness

Full study title

Efficacy of sertraline for palliative management of refractory breathlessness

ANZCTR Trial ID

ACTRN12610000464066 (opens external site)

Aim

To test the efficacy of sertraline compared with placebo in relieving the sensation of intractable breathlessness. and to focus on the impact of the sertraline on improving quality of life (QOL), breathlessness-related anxiety and depression, adverse effects, function and clinical predictors of benefit.

Summary

Breathlessness is a major clinical problem for many people with advanced progressive illnesses. These illnesses include chronic obstructive pulmonary disease, end-stage cardiac failure and cancer.

Although there are some interventions that may offer benefit (oxygen therapy, sustained-release low-dose morphine), there is still a need for a wider range of interventions to meet the needs of people with chronic breathlessness.

Sertraline is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is primarily used to treat major depression as well as obsessive-compulsive, panic, and social anxiety disorders.

Previous research suggested that treatment of concomitant mood or anxiety symptoms could improve breathlessness. Further studies were needed to clarify potential benefits in the treatment of breathlessness.

The research team conducted a phase III pilot study that demonstrated acceptability and feasibility of this study. This phase III study was needed to determine that sertraline was a well-tolerated and effective intervention for a broad range of people with chronic breathlessness.

This study evaluated a new but theoretically useful therapy whose role needs to be carefully defined to determine if there is evidence of a net clinical benefit.

Funding

Commonwealth Department of Health and Ageing
National Health and Medical Research Council

SKIPMDD study

Investigators

The Coordinating Principal Investigator is Dr Wei Lee.

The investigation team includes Dr Caitlin Sheehan, Dr Amy Chow, Associate Professor Richard Chye, Professor Colleen Loo, Professor Brian Draper, Professor Meera Agar and Professor David Currow.

Trial status

This clinical trial is open. More information is available from paccsc@uts.edu.au.

Health condition

Major depressive disorder in palliative care patients.

Full study title

Subcutaneous Ketamine Infusion in Palliative Care Patients with Advanced Life Limiting Illness for Major Depressive Disorder: A phase II feasibility study (SKIPMDD)

Trial ID

ACTRN12618001586202 (opens external site)

Aim

This study aims to find out whether it is possible to use ketamine for depression in those with advanced illness. It will look at how:

many people with advanced illnesses are happy to receive ketamine
easy it is to use the medication
well people receive it
useful it is to help with depression
satisfied people are with using ketamine to help depression
satisfied people are with the overall trial process

Summary

Depression (Major Depressive Disorder) is common in people with advanced illnesses. Usual medications for depression can take up to a few weeks to work. These medications might not work in time for palliative care patients with advanced illnesses. Something different is needed that will work quickly for depression in palliative care patients.

Ketamine is a familiar medication. It has been used in anaesthetics, pain and palliative care. At low doses, ketamine has been found to help otherwise well people with difficult-to-treat depression. It works quickly and effectively. However, it has not yet been tested in people with advanced illnesses.

Eligibility

You may be eligible to participate in this study if you are 18 years or older, in palliative care and have been identified as having a major depressive disorder.

Participating sites

Braeside Hospital
Liverpool Hospital
St Vincent's Hospital Sydney
Calvary Kogarah

Funding

Palliative Care Clinical Studies Collaborative