MethylphenIdate for Fatigue in Haematological Cancer

• Status: Unknown status
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henrik Frederiksen; Odense University Hospital
• Treatments: Methylphenidate

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