Methylphenidate for patients with haematological cancer – the MICRO trial

Phase 1

• Conditions: Cancer related fatigue in patients with haematological cancer disease; MedDRA version: 20.1Level: LLTClassification code 10066564Term: Chronic fatigueSystem Organ Class: 100000004867; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-001844-36-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-21
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

•Malignant haematological disease such as
oMyeloproliferative neoplasm
oMyelodysplasia / Acute Myeloid Leukemia / Chronic Myelomonocytic leukemia
oAcute lymphoblastic leukemia
oMalignant lymphoma
oChronic lymphocytic leukemia
oMultiple 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

•Chemotherapy within last 8 weeks. Patients on a stable dose previous 4 weeks of the following, may be included:
oKinase inhibitors (such as Imatinib, Dasatininb, otinib, Ruxulitinib, Bosutinib and others)
oHydroxyurea
oChlorambucil
oBusulfan
oMelphalan
oalfa-interferon
oIMIDs (such Thalidomide, Lenalidomide, Pomalidomide and others)
omonoclonal anti-bodies
o5-azacytidin
oCombinations 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study if methylphenidate is superior compared to placebo in relieving fatigue and thereby improving<br>•hours awake<br>•time spend at work, being social, house work / gardening, being outside, participating in excercise<br>•WHO performance status<br>•muscle strength and endurance<br>•quality-of-life<br>•number of blood transfusions<br>;Secondary Objective: NA;Primary end point(s): Primary end-point<br>•Patient reported fatigue reduction after six weeks of MTP treatment measured by FACIT-F scale.<br>;Timepoint(s) of evaluation of this end point: End of six weeks, end of 13th week and end of study 15th week

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary end-points<br>•Changes in hours awake<br>•Changes in time spend at work, being social, house work / gardening, being outside, participating in excercise<br>•Changes in WHO performance status<br>•Changes in muscle strength and endurance<br>•Changes in quality-of-life<br>•Changes in number of blood transfusions<br>;Timepoint(s) of evaluation of this end point: End of six weeks, end of 13th week and end of study 15th week