Symptom Control Trials in Patients With Advanced Cancer: A Qualitative Study

Middlemiss, Tom; Lloyd‐Williams, Mari; Laird, Barry; Fallon, Marie

doi:10.1016/j.jpainsymman.2015.05.009

Cited by 25 publications

(17 citation statements)

References 23 publications

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“…Currently, the majority of symptom control practice is based on either historical anecdote or low-level evidence, and the lack of research is paradoxical to its importance. 29 There is a need for well-designed clinical trials that either support or (as in our trial) refute practice. We have demonstrated that undertaking symptom control trials in patients with cancer is feasible.…”

Section: Discussionmentioning

confidence: 89%

Randomized Double-Blind Trial of Pregabalin Versus Placebo in Conjunction With Palliative Radiotherapy for Cancer-Induced Bone Pain

Fallon

Hoskin

Colvin

et al. 2016

JCO

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PurposeCancer-induced bone pain (CIBP) affects one third of patients with cancer. Radiotherapy remains the gold-standard treatment; however, laboratory and clinical work suggest that pregabalin may be useful in treating CIBP. The aim of this study was to examine pregabalin in patients with CIBP receiving radiotherapy.Patients and MethodsA multicenter, double-blind randomized trial of pregabalin versus placebo was conducted. Eligible patients were age ≥ 18 years, had radiologically proven bone metastases, were scheduled to receive radiotherapy, and had pain scores ≥ 4 of 10 (on 0-to-10 numeric rating scale). Before radiotherapy, baseline assessments were completed, followed by random assignment. Doses of pregabalin and placebo were increased over 4 weeks. The primary end point was treatment response, defined as a reduction of ≥ 2 points in worst pain by week 4, accompanied by a stable or reduced opioid dose, compared with baseline. Secondary end points assessed average pain, interference of pain with activity, breakthrough pain, mood, quality of life, and adverse events.ResultsA total of 233 patients were randomly assigned: 117 to placebo and 116 to pregabalin. The most common cancers were prostate (n = 88; 38%), breast (n = 77; 33%), and lung (n = 42; 18%). In the pregabalin arm, 45 patients (38.8%) achieved the primary end point, compared with 47 (40.2%) in the placebo arm (adjusted odds ratio, 1.07; 95% CI, 0.63 to 1.81; P = .816). There were no statistically significant differences in average pain, pain interference, or quality of life between arms. There were differences in mood (P = .031) and breakthrough pain duration (P = .037) between arms. Outcomes were compared at 4 weeks.ConclusionOur findings do not support the role of pregabalin in patients with CIBP receiving radiotherapy. The role of pregabalin in CIBP with a clinical neuropathic pain component is unknown.

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Section: Discussionmentioning

confidence: 89%

Randomized Double-Blind Trial of Pregabalin Versus Placebo in Conjunction With Palliative Radiotherapy for Cancer-Induced Bone Pain

Fallon

Hoskin

Colvin

et al. 2016

JCO

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“…However, the need for symptom control studies in patients with cancer has been advocated. 26 One of the key challenges in this area is that patients with advanced cancer are complex and the etiology behind their nausea and vomiting is often multifactorial. Common causes include drugs such as opioids, delayed gastric emptying, mechanical bowel obstruction, increased intracranial pressure, vestibular dysfunction, metabolic problems, and cortical effects such as anxiety or depression.…”

Section: Discussionmentioning

confidence: 99%

The Management of Opioid-Induced Nausea and Vomiting in Patients with Cancer: A Systematic Review

Sande

Laird

Fallon

2019

Journal of Palliative Medicine

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Background: Opioids are the foundation of treatment for cancer pain but can cause side-effects, one of the most common being nausea and vomiting, which can impair quality of life. Objective: To evaluate the evidence for the management of opioid-induced nausea and vomiting. This systematic review was undertaken as part of an update of the European Association for Palliative Care's opioid guidelines. Design: Searches of MEDLINE (1966-2017) and EMBASE (1980-2017) were done. Key eligibility criteria were: randomized controlled trials conducted in patients with cancer. The Grading of Recommendations Assessment Development and Evaluations system was applied to formulate recommendations. Results: Fifteen studies were eligible (1524 patients). The studies were grouped as follows: opioid switching (n = 8); the use of antiemetics to treat opioid-induced nausea and vomiting (n = 4); and change of route of administration of the opioid (n = 3). Three recommendations were formulated: A weak recommendation for switching from morphine to oxycodone in cancer patients with nausea (quality D); a weak recommendation for switching from tramadol to either codeine or hydrocodone for pain in cancer patients with nausea (quality D); and a weak recommendation for switching from morphine/oxycodone to methadone using the three-day switch method in patients with increasing pain considered untreatable with further opioid titration and/or with opioidrelated side effects (quality C). Conclusions: This systematic review can make only weak recommendations for the management of opioidinduced nausea and vomiting. There remains a need for high-quality studies before strong recommendations on the management of opioid-induced nausea and vomiting can be made.

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“…For example, a study looking at the patient experience of taking part in a clinical trial described that, even in the absence of any improvement in physical symptoms, participant overall well-being was improved after taking part. 12 The authors discussed the personal value patients took from adopting altruistic motives as well as the potential to benefit from the relationship that they build with researchers. This ties with what is known about well-being in those that are terminally ill where themes of self-awareness, the existence of positive and meaningful relationships with others and the capacity for continued meaning are described as central.…”

Section: Interviewing In the Palliative Care Context -Mr Smithmentioning

confidence: 99%

Relational ethics in palliative care research: including a person-centred approach

Haraldsdottir

Lloyd²,

Dewing

2019

Palliat�Care

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The traditional approach to research ethics is to ensure that all ethical issues are adhered to through the scrutiny of research proposals by research ethics committees, themselves sitting within national research governance frameworks. The current approach implies that all potential ethical issues can be considered and mitigated prior to the research. This article is a perspective piece whereby we consider how this approach, on its own, is not enough to ensure ethical practice. We draw attention to the limitations of current ethical procedures in the inherent detachment between the researcher and research participants. We argue that applying a person-centred approach to research ethics allows for contextual and situational factors and places the relationship between research participants and researcher as central.

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Symptom Control Trials in Patients With Advanced Cancer: A Qualitative Study

Cited by 25 publications

References 23 publications

Randomized Double-Blind Trial of Pregabalin Versus Placebo in Conjunction With Palliative Radiotherapy for Cancer-Induced Bone Pain

Randomized Double-Blind Trial of Pregabalin Versus Placebo in Conjunction With Palliative Radiotherapy for Cancer-Induced Bone Pain

The Management of Opioid-Induced Nausea and Vomiting in Patients with Cancer: A Systematic Review

Relational ethics in palliative care research: including a person-centred approach

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