Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo.

INTRODUCTION: Methylphenidate is a psychostimulant drug used to treat fatigue in patients with advanced cancer, for which there is no gold standard of treatment. OBJECTIVE: To explore the efficacy of methylphenidate in the relief of fatigue in patients with advanced cancer. MATERIALS AND METHODS: A randomised double-blind placebo-controlled multicentre clinical trial, stratified according to the intensity of fatigue. The treatment was considered effective if the improvement in mean fatigue intensity between baseline values and day 6 was significantly higher in the methylphenidate group than in the placebo group. The responses were measured using the Edmonton Symptoms Assessment System (ESAS) and the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scales. RESULTS: 35 patients received placebo and 42 patients received methylphenidate. The populations of both groups were homogeneous. Patients receiving methylphenidate did not exhibit statistically significant improvement of fatigue in comparison to patients receiving placebo (p=0.52). The mean improvement of fatigue (ESAS) on day 6 was -1.9 (±2.5) in the placebo group, and -2.3 (±2.6) in the methylphenidate group (p=0.52). The results obtained with the FACT-F were congruent with those obtained by the ESAS. The responses in patients with severe fatigue were -2.4 (±2.9) in the placebo group and -3.4 (±2.5) in the methylphenidate group; the difference was not statistically significant (p=0.3). CONCLUSION: Methylphenidate was not more efficient than placebo to treat cancer-related fatigue. Fatigue improved significantly after 3 days of treatment and was stabilised on day 6, both with placebo and methylphenidate. The side effects of methylphenidate were mild and infrequent. TRIAL REGISTRATION NUMBER: EudraCT Registry (2008-002171-27).

A new palliative care consultation team at the oncology department of a university hospital: an assessment of initial efficiency and effectiveness.

PURPOSE: Palliative care consultation teams (PCCT) in acute hospitals have increased in number over recent years. To assess whether these teams are both efficient in their role within a palliative care centre and effective in the care that is provided for patients, we reviewed the initial activity of a new PCCT at the Oncology Department of Clínica Universidad de Navarra, a European Society for Medical Oncology-designated centre of integrated oncology and palliative care. METHODS: All patients evaluated by the PCCT over the first 3 years of its activity were included. Data about diagnosis, demographic characteristics, survival and initial symptom burden were evaluated using the Edmonton Symptom Assessment System (ESAS); whenever possible, a follow-up ESAS for inpatients was collected within 1 week from the electronic charts and analysed retrospectively. RESULTS: The PCCT evaluated 611 cancer patients within the initial 3 years of the service commencing. On the first visit, 392 patients (64%) completed the ESAS evaluation. Of those that completed the ESAS, 43% were outpatients, 52% had gastrointestinal tumours, and 16% died within a month. The evaluated patients had an average of six uncontrolled symptoms (≥4/10). The most common moderate to severe symptoms were fatigue (80%), anorexia (67%) and depression (62%); 70% of patients presented with pain (14% with severe pain). Of the 225 inpatients evaluated, 110 (49%) completed the follow-up ESAS within 1 week. A statistically significant decrease was observed for pain, nausea, depression, anxiety and somnolence as well as in the number of uncontrolled symptoms and in the symptom distress score. The patient's perception of his/her general well-being was better as meassured with the specific question of ESAS. CONCLUSION: From the initial stages, the PCCT was both efficient in its role within the palliative care centre and effective in the care that was provided for patients. A significant number of patients were evaluated, many of them with severe symptoms and/or at the end of life. Inpatients receiving care from the PCCT experienced an improvement in symptom control within just a few days.

Impact of a new palliative care consultation team on opioid prescription in a University Hospital.

BACKGROUND: There are no validated measuring tools to gauge the effectiveness of a Hospital Palliative Care Consultation Team (PCCT). One way would be to consider its effect on the consumption of opioids expressed in total amounts and different formulations administered. We perform this study to evaluate the impact of a hospital PCCT on the trends of opioid prescription in a University Hospital. METHODS: A seven year retrospective study on opioid prescription was carried out in the Clínica Universidad de Navarra. The period includes three years before and three years after the PCCT was implemented. Prescription was analysed calculating yearly the Defined Daily Dose (DDD) adjusted to 1000 hospital stays (DDD/1000HS). Indicators considered were the proportion of patients treated using opioids compared to the total estimated in need of treatment (rate of effectiveness) and the proportion of patients potentially requiring opioids but not treated who were incorporated into the treatment group (rate of improvement). RESULTS: From 2001 to 2007, total opioid prescription was low in non-oncology Departments (range: 69-110 DDD/1000HS) while parenteral morphine and fentanyl did not register any changes. In the same period of time, total opioid prescription increased in the Oncology Department from 240 to 558 DDD/1000HS. The rate of effectiveness in the three years prior to the implantation of the consultation team was 64% and in the three following years rose to 87%. The rate of improvement prior to the palliative care consultation team was 43% and in the three following years was 64%. A change in opioid prescription was registered after the implementation of the PCCT resulting in an increase in the prescription of parenteral morphine and methadone and a decrease in transdermal fentanyl. CONCLUSION: Implementation of a PCCT in a University Hospital is associated with a higher and more adequate use of opioids.