Psychosocial Oncology and Survivorship Cancer Cancer/ Malignant neoplasms of ill-defined, secondary and unspecified sites
Conditions
Interventions
MePFAC is a prospective, randomised, double-blind, placebo-controlled trial with internal pilot in palliative care patients with advanced cancer.
The MePFAC study aims to recruit 230 patients across
the centre, receipt of palliative cancer treatment, baseline HADS depression score, and whether patients are considered to be “severely” fatigued (initial fatigue score >7/10 on a numerical rating sca
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 28/10/2018 (updated 27/07/2023): 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 Previous inclusion criteria: 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. Prognosis 2-12 months (as estimated by clinician) 6. Able and willing to comply with all study requirements, including ability to participate in study for nine weeks 7. Under the care of a specialist palliative care team 8. Willing to allow his or her General Practitioner to be notified of participation in the study
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 28/10/2018 (updated 27/07/2023): 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 six 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 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 1 year) or known high-risk factors for cerebrovascular disorders 15. Current or previous psycho-stimulant use in the last month 16. Severe anaemia (haemoglobin 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 1 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare fatigue, measured by Functional Assessment of Chronic Illness Therapy (FACIT-F), in patients with advanced cancer receiving individually titrated doses of methylphenidate with patients receiving placebo after six weeks’ treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life is measured using the 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]) at 3, 6 and 9 weeks 2. Adverse events are documented on the case report form (as mild, moderate or severe) at 3, 6 and 9 weeks 3. Activities of daily living is measured using the mobility, self-care and usual activity domains of the EQ-5D-5L at 3, 6 and 9 weeks 4. Appetite is measured using the anorexia item on the EORTC QLQ-C15-PAL at 3, 6 and 9 weeks 5. Satisfaction of patients and carers are measured using the Global benefit score (GBS) at 3, 6 and 9 weeks 6. Survival of patients after recruitment is measured by asking patients for permission to flag their records with the NHS Information Centre (NHS IC) at 3, 6 and 9 weeks 7. Need for other medication specifically steroids, antidepressants, anxiolytics and analgaesics) will be measured by asking participants about concomitant medication use at baseline and at week six | — |
Countries
England, United Kingdom
Contacts
Public ContactElli Enayat
Outcome results
None listed