Methylphenidate versus placebo for fatigue in advanced cancer (MePFAC)
- Conditions
- MedDRA version: 20.0Level: PTClassification code 10016256Term: FatigueSystem Organ Class: 10018065 - General disorders and administration site conditionsCancer-related fatigueTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001950-33-GB
- Lead Sponsor
- C
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 215
1.Aged 18 years or over
2.Participant is willing and able to give informed consent for participation
3.Advanced incurable cancer of all tumour types
4.Moderate or severe fatigue (>3/10 on a numerical rating scale)
5.Able and willing to comply with all study requirements, including ability to participate in study for ten weeks
6.Participant is receiving generalist or specialist palliative care
7.Willing to allow his or her General Practitioner to be notified of participation in the study
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 115
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 115
1.Pregnancy
2.Females of childbearing potential and males who have sexual partners with child-bearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; true abstinence) from the time consent is signed until 6 weeks after treatment discontinuation and inform the trial if pregnancy occurs. For the purpose of clarity, true abstinence is when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence, withdrawal, spermicides only or lactational amenorrhoea method for the duration of a trial, are not acceptable methods of contraception)
3.Females of childbearing potential must have a negative pregnancy test seven days or fewer prior to first dose administration and must be willing to have a pregnancy test at every physical visit during the study
4.Females must not be breastfeeding
5.Known sensitivity to methylphenidate or to any of the excipients
6.History of glaucoma
7.Known phaechromocytoma
8.Planned general anaesthesia in the next nine weeks
9.During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs
10.Clinical Hyperthyroidism or thyrotoxicosis. Patients must have a thyroid function test (T4 and TSH) showing no evidence of hyperthyroidism in three months prior to first dose administration of study medication
11.Known diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder
12.Known diagnosis or history of severe and episodic (Type 1) bipolar (affective) disorder (that is not well controlled)
13.Known pre-existing cardiovascular disorders including severe hypertension (BP >160/100mmHg), uncontrolled heart failure uncontrolled angina, arterial occlusive disease, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction (within last one year), potentially life-threatening arrhythmias and channelopathies
14.Pre-existing cerebrovascular disorders, cerebral aneurysm, vascular abnormalities including vasculitis or stroke (within last one year) or known high risk factors for cerebrovascular disorders
15.Current or previous psycho-stimulant use in last month
16.Severe anaemia (Haemoglobin < 80g/L)
17.Platelets <50 × 103/µL
18.White blood count less than 1.5 x 109/litre
19.Any evidence of severe or uncontrolled infection that in the view of the investigator makes it undesirable for the patient to participate in the trial
20.Estimated glomerular filtration rate [eGFR] <45 ml/minute per 1·73 m²
21.ALT > 2 x ULN or bilirubin > 1.5 x ULN
22.Participating in another research study involving any investigational agents within four weeks prior to registration
23.Insufficient English language skills to understand study documentation and complete assessments
24.Current treatment with clonidine, warfarin, monoamine oxidase inhibitors or modafinil
25.History of previous or current substance or alcohol dependency within the last one year
26.Unable to swallow tablets/capsules
27.History of poorly controlled epilepsy, or seizures related to underlying brain tumour
28.Any other significant disease or disorder which, in the opinion of the Investigator, may put the partici
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: What is the clinical effectiveness of methylphenidate versus placebo for cancer-related fatigue in patients receiving palliative care?;Secondary Objective: 1. What are the effects of methylphenidate (versus placebo) on quality of life; mood; and activities of daily living in patients receiving palliative care?<br><br>2. What are the adverse effects of methylphenidate (versus placebo) in patients receiving palliative care?;Primary end point(s): Primary outcome is fatigue at 6 weeks measured by the fatigue sub-scale of Functional Assessment of Chronic Illness Therapy (FACIT-F). ;Timepoint(s) of evaluation of this end point: 6 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary outcomes are other measures of quality of life (using European Organisation for Research and Treatment of Cancer core Quality of Life Palliative Care questionnaire [EORTC QLQ-C15-PAL] and the EuroQol EQ-5D 5 level [EQ-5D-5L]), adverse events, activities of daily living; appetite; satisfaction of patients and carers; survival and need for other medication.;Timepoint(s) of evaluation of this end point: 3, 6 and 10 weeks