Patients with cancer in palliative stage of their illness. Suffering from fatigue with or without decreased concentration, depression or drowsiness, who feel their fatigue is severe enough to decrease their quality of life.
Conditions
Interventions
Trade Name: Ritalin
Product Name: Methylphenidate hydrochloride
Pharmaceutical Form: Tablet
INN or Proposed INN: Methylphenidate Hydrochloride
CAS Number: 298-59-9
Concentration unit: mg milligram(s)
Sponsors
Southampton University Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Any patient, known to have cancer, entering the Countess Mountbatten Service who describes drowsiness, fatigue, tiredness, lethargy, decreased concentration or other similar symptom that is interfering with their daily living or quality of life. • With or without symptoms and signs of clinical depression. • Must be capable of understanding the patient leaflet though this may be read for them. • Must be willing to give written consent (unless physical disability prevents this at which time audio recorded verbal consent will be accepted). Audio-recorded verbal consent will be stored as with the rest of the study audio recordings for 15 years on Digital Video Disc. • Aged 18 years or over • Patient aware of diagnosis • Patient well enough to undertake study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: As identified by the manufacturers data sheet; • A history of on-going hypertension requiring medical treatment. • A previous history of agitated psychosis whether alone or as part of delirium, depression or other psychiatric illness. • A previous history of anxiety attacks or anxiety disorder. Study considerations; • Patients GP unwilling to consider continuation of treatment following trial if the patient wishes it. • Involvement in another concurrent research trial. • Use of alternative remedies with unknown side effect profiles and possible interactions with the trial drug. • Patient imminently dying. • No telephone available at their place of residence, as this will make patient follow up much more difficult and may introduce delays in reporting of side effects. • Significant deafness, speech impediment or other disability leading to recording of interviews being impossible. • Patient not able to converse in English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: b) To explore whether there are any consistent or common patterns of effects between patients, independent of the perceived cause of their fatigue. c) To explore the fatigue experience of patients who fail to respond to amphetamine. d) To obtain scores from 3 Fatigue scales and by comparison to ascertain which of these scales might be more appropriate to use in a later pilot double blind placebo controlled trial of methylphenidate treatment in this group of patients. ;Main Objective: To investigate the actual effects of methylphenidate on these patients. Following up small prospective studies in palliative care or medically unwell patients where methylphenidate has been shown to be effective as a treatment for fatigue, depression or concentration seperately. None has looked at the effects of the more nebulous syndrome of fatigue. a) To identify the main areas of “fatigue” that amphetamine acts upon in different patients.;Primary end point(s): Completion of 5 days of amphetamine treatment with a qualitative interview on the last day of treatment. | — |
Countries
United Kingdom
Outcome results
None listed