Cancer related fatigue in patients with haematological cancer disease MedDRA version: 20.1 Level: LLT Classification code 10066564 Term: Chronic fatigue System Organ Class: 100000004867
Conditions
Interventions
Trade Name: Methylphenidate Alternova
Product Name: Methylphenidate
Pharmaceutical Form: Tablet
INN or Proposed INN: METHYLPHENIDATE
CAS Number: 113-45-1
Concentration unit: mg milligram(s)
Concentrat
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Malignant haematological disease such as o Myeloproliferative neoplasm o Myelodysplasia / Acute Myeloid Leukemia / Chronic Myelomonocytic leukemia o Acute lymphoblastic leukemia o Malignant lymphoma o Chronic lymphocytic leukemia o Multiple myeloma • Patient reported fatigue equals to a VAS score of 4 or more on a scale of 0 to 10 on (0 = no fatigue to 10 = worst possible fatigue). Score must be the patients retrospective estimate of usual fatigue during the past two weeks • Out-patient at inclusion • Hb = 5 mmol/l on the past three hb measurements • Age = 18 years • Ability to read and understand Danish language • Safe contraception for fertile women 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: • Chemotherapy within last 8 weeks. Patients on a stable dose previous 4 weeks of the following, may be included: o Kinase inhibitors (such as Imatinib, Dasatininb, Nilotinib, Ruxulitinib, Bosutinib and others) o Hydroxyurea o Chlorambucil o Busulfan o Melphalan o alfa-interferon o IMIDs (such Thalidomide, Lenalidomide, Pomalidomide and others) o monoclonal anti-bodies o 5-azacytidin o Combinations of above mentioned drugs and with corticosteroids (CS) are allowed as long as CS dose restrictions are followed. • Glucocorticoid treatment exceeding the equal of prednisolone 10mg / day or equivalent average dose / week and dosage must have remained stable during the past 4 weeks. • Current infection • Previous or current diagnosis made by a psychiatrist of psychosis, mania, or Tourette • Known previous suicidal attempts • Current psycho-pharmacological treatment • Known cardio-vascular disease. Patients with known stable angina pectoris may be included. • Prolonged QT interval corrected (QTc) >500msec at screening ECG • Known cerebro-vascular disease • Uncontrolled hypertension defined as SBP > 160 mmHg or DBP > 100mmHg • Cognitive impairment as judged by investigator • Change in opiod dose during the past two weeks • Life expectancy < 4 months • EPO started or dosage changed < 6 weeks prior to inclusion • Hypothyroidism with thyroid hormone supplementation treatment started or dosage changed < 6 weeks before inclusion • Known hyperthyroidism • Known pheochromocytoma • Known glaucoma • Previous or current substance abuse • Use of monoamine oxidase inhibitors within last two weeks • Known allergy to or side-effects from previous methylphenidate treatment • Pregnancy or breast feeding • Serious medical illness which in the judgement of the investigator would make the patient inappropriate for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study if methylphenidate is superior compared to placebo in relieving fatigue and thereby improving •hours awake •time spend at work, being social, house work / gardening, being outside, participating in excercise •WHO performance status •muscle strength and endurance •quality-of-life •number of blood transfusions ;Secondary Objective: NA;Primary end point(s): Primary end-point •Patient reported fatigue reduction after six weeks of MTP treatment measured by FACIT-F scale. ;Timepoint(s) of evaluation of this end point: End of six weeks, end of 13th week and end of study 15th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end-points • Changes in hours awake • Changes in time spend at work, being social, house work / gardening, being outside, participating in excercise • Changes in WHO performance status • Changes in muscle strength and endurance • Changes in quality-of-life • Changes in number of blood transfusions ;Timepoint(s) of evaluation of this end point: End of six weeks, end of 13th week and end of study 15th week | — |
Countries
Denmark
Contacts
Public ContactHenrik Frederiksen
Odense University Hospital
Outcome results
None listed