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MethylphenIdate for Fatigue in Haematological Cancer (MICRO)

This study is not yet open for participant recruitment.
Verified July 2017 by Henrik Frederiksen, Odense University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03218254
First Posted: July 14, 2017
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Henrik Frederiksen, Odense University Hospital
  Purpose
Cancer related fatigue (CRF) is the most debilitating problem for patients with haematological cancer. CRF severely reduces quality of life (QoL), functional capacity, impacts health behavior, recovery and furthermore no approved treatment exists. In solid cancer methylphenidat (MTP) has been suggested to improve CRF, however patients with haematological cancer has not been studied. The current randomized placebo controlled study includes a variety of severely fatigued haematological cancer patients from seven Danish departments. It aims at revealing whether MTP can improve CRF, functional capacity and QoL thereby hopefully providing improvement and treatment options in this field where improvements are requested the most by patients. Patients are randomized to treatment with MTP or placebo week 1-6 followed by "wash-out" and cross-over - placebo to MTP or vice versa - during week 8-13. End-points will be patient reported fatigue, as well as improvements in active hours, functional capacity, and QoL.

Condition Intervention Phase
Hematological Cancer Drug: Methylphenidate Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Methylphenidate or Placebo titrated according to effect and toxicity week 1-6 followed by 1 week of washout and then crossover followed by repeated procedures with the other treatment for week 8-13.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Identical placebo tablets are produced. Study pharmacy produces study medication containers and randomizes patients, and keeps track of unique study IDs. Unblinding is only done after completion or in emergency situations
Primary Purpose: Treatment
Official Title: MethylphenIdate for Fatigue in Haematological Cancer. A Randomized, Double-blind, Placebo-controlled, CROssover Trial - the MICRO Trial

Resource links provided by NLM:


Further study details as provided by Henrik Frederiksen, Odense University Hospital:

Primary Outcome Measures:
  • Fatigue score [ Time Frame: end of 6th or 13th week ]

Estimated Enrollment: 150
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: October 1, 2021
Estimated Primary Completion Date: October 1, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Methylphenidate - Placebo
Methylphenidate before placebo
Drug: Methylphenidate
Titration of MTP for treatment of fatigue
Drug: Placebo
Placebo
Placebo - Methylphenidate
Methylphenidate after placebo
Drug: Methylphenidate
Titration of MTP for treatment of fatigue
Drug: Placebo
Placebo

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Malignant haematological disease such as

    • Myeloproliferative neoplasm
    • Myelodysplasia / Acute Myeloid Leukemia / Chronic Myelomonocytic leukemia
    • Acute lymphoblastic leukemia
    • Malignant lymphoma
    • Chronic lymphocytic leukemia
    • 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

Exclusion Criteria:

  • Chemotherapy within last 8 weeks. Patients on a stable dose previous 4 weeks of the following, may be included:

    • Kinase inhibitors (such as Imatinib, Dasatininb, Nilotinib, Ruxulitinib, Bosutinib and others)
    • Hydroxyurea
    • Chlorambucil
    • Busulfan
    • Melphalan
    • alfa-interferon
    • IMIDs (such Thalidomide, Lenalidomide, Pomalidomide and others)
    • monoclonal anti-bodies
    • 5-azacytidin
    • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218254


Locations
Denmark
Odense University Hospital Not yet recruiting
Odense, Danmark, Denmark, 5000
Contact: Henrik Frederiksen, MD, PhD       henrik.frederiksen@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
  More Information

Responsible Party: Henrik Frederiksen, MD, PHD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03218254     History of Changes
Other Study ID Numbers: EUDRACT 2017-001844-36
First Submitted: July 13, 2017
First Posted: July 14, 2017
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Henrik Frederiksen, Odense University Hospital:
hematological cancer, fatigue, quality of life

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents