Methylphenidate Versus Placebo for Treating Fatigue in Patients With Advanced Cancer: Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial.

PURPOSE: To compare effects and side effects of 6 weeks of individually dose-titrated methylphenidate or placebo on fatigue in palliative care patients with advanced cancer. METHODS: This is a randomized, double-blind, placebo-controlled, multicenter trial. Eligible patients had advanced incurable cancer and fatigue >3/10. Principal exclusions were hypertension; psychiatric, cardiovascular, cerebrovascular, renal, liver, or blood disorders; substance dependency; and epilepsy. Patients were randomly assigned 1:1 methylphenidate or placebo starting at 5 mg twice daily. Dose of methylphenidate/placebo was titrated once per week, over 6 weeks, up to a maximum of 20 mg three times daily. Trial ended at 10 weeks. Primary outcome was the difference in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scores between groups at 6 ± 2 weeks. Secondary outcomes included adverse effects, quality of life, and mood. RESULTS: One hundred sixty-two patients (73 men; mean, 65.8; standard deviation [SD], 10.3 years) were randomly assigned, and three were excluded from analysis. Seventy-seven were allocated placebo (baseline FACIT-F = 22 [SD, 10]); 82 were allocated methylphenidate (FACIT-F = 20 [SD, 9]). After 6 ± 2 weeks, FACIT-F scores were 1.97 points (95% CI, -0.95 to 4.90; P = .186) higher (better) on methylphenidate than placebo. Across 10 weeks of the study, FACIT-F was nominally higher in the methylphenidate group versus placebo (Diff, 2.20 [95% CI, 0.39 to 4.01]), but this did not reach the minimally clinically important difference (5-points). At 6 weeks, there were no differences between groups in quality-of-life or symptom domains except for depression scores (nominally reduced in the methylphenidate group: Diff, -1.35 [95% CI, -2.41 to -0.30]). There were no differences in mortality or serious adverse events. CONCLUSION: After 6 ± 2 weeks of treatment, methylphenidate was not superior to placebo for treating fatigue in advanced cancer. Methylphenidate was safe and well-tolerated.

Identification of factors associated with cancer related fatigue syndrome in disease-free breast cancer patients after completing primary treatment.

This study is an analysis of variables associated with women who meet the criteria for after completion of successful primary treatment for breast cancer. This analysis was conducted to identify factors independently associated with cancer related fatigue syndrome using a combined dataset from two non-overlapping studies conducted on similar populations. Participants who were clinically (and radiologically) disease-free, between 3 months and 2 years after treatment, were recruited from a single centre. A diagnostic interview was conducted to ascertain whether they met the criteria for cancer related fatigue syndrome. We analysed a number of treatment, laboratory and questionnaire variables between groups. Those that were significantly different were entered into a logistic model. A total of 278 subjects (105 cases of cancer related fatigue syndrome and 173 controls who did not meet the criteria) were analysed. A number of questionnaire responses were significantly different including all of the European Organisation for the Research and Treatment of Cancer core 30 item quality of life questionnaire (EORTC QLQ c30) and Breast questionnaire 23 item subgroup scores. 11 variables were entered into the final model and 5 were independently associated with cancer related fatigue syndrome: Hospital anxiety and depression scale score, EORTC pain and insomnia scales, breast systemic side effects and plasma sodium. There was, however, no association with demographic or treatment variables. As a conclusion, cancer related fatigue syndrome after treatment is linked with sub-clinical mood pain and subjective sleep disturbance and with the side effects of systemic treatment. This study is unable to determine whether these associations are causal, but they provide a potential target for interventions to manage the symptoms of cancer related fatigue syndrome.

Evaluating a fast-track discharge service for patients wishing to die at home.

BACKGROUND: The UK Department of Health's End of Life Care Strategy highlighted the low percentage of patients who achieve their wish to die at home (~20%). Figures in south west London were below the London regional average. This paper reports an attempt to improve the proportion of patients from one hospital in the area achieving their preferred place of death. METHODOLOGY: A funded initiative by two local primary care trusts allowed the development of a 7-day-per-week fast-track discharge service provided by the hospital palliative care team. The hospital team acted as coordinators, ensured that the correct medication and equipment would be available at the home, and personally transferred the patients to community services. RESULTS: Data is presented from the first representative period of fast-track discharging (June 2009-July 2010). A total of 110 discharges were facilitated over this time, with the rate increasing as the service developed. The vast majority of discharges occurred within 72 hours, and a significant number (~20%) occurred within 24 hours. CONCLUSIONS: The data indicate that the new service is effective. There are logistical problems in providing such a service and these are discussed. Further work is required to determine the feasibility of extending this service model to other acute hospitals and to evaluate its health-economic impact.

Achieving the preferred place of care for hospitalized patients at the end of life.

BACKGROUND: The Department of Health end-of-life strategy contains a number of quality markers which include taking into account patients' wishes for their final place of care. There is a wide variation in how this information is recorded. METHODS: An audit was conducted on discussion of preferred place of care (PPC) for all patients referred to the hospital palliative care team who died during the audit period. Barriers to achieving PPC and the efficacy of a fast track discharge service were also monitored. The audit was first done in 2007 and was repeated in 2009. RESULTS: There was an increase in recording PPC. Overall PPC wishes were ascertained for 87% of the patients seen by the team. The PPC was achieved in 76% of cases. The number of patients wishing to die in hospital significantly increased over the audit cycle (from 10% to 30%). Approximately one-third of patients changed their minds regarding PPC. CONCLUSIONS: The data highlights the need to distinguish between preferred place of care and preferred place of death. Patients' wishes regarding PPC change as death approaches. A greater number of patients wished to die in hospital than was expected.