EUCTR2017-001844-36-DK进行中（未招募）1 期
MethylphenIdate for fatigue in haematological cancer. A randomized, double-blind, placebo-controlled, CROssover trial - the MICRO trial - MICRO trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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
研究者
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