Short summary

The study is a double-blind, randomized, placebo controlled, clinical crossover trial aiming at examining whether methylphenidate can be used for treatment of cancer related fatigue in haematological cancer patients. Participants will be recruited from 7 participating haematology departments throughout Denmark. 

Rationale

In the past decades survival prognosis in most haematological malignancies has improved considerably and accordingly the prevalence of such patients has increased almost fivefold. Although improvement has been made in cancer treatment and supportive care management of one of the most prevalent and debilitating symptom - cancer related fatigue (CRF) - has not improved. The prevalence and impact of fatigue in cancer patients is huge were half of patients who have received chemotherapy within the last year report significant fatigue disproportionate with activities, 39% report non-restorative sleep, and 38% has experienced difficulties in completing daily tasks due to fatigue. CRF severely reduces quality of life (QoL), functional capacity, impacts health behavior, recovery and furthermore no approved treatment exists. Haematological patients express that their single most prevalent and severe unmet need is "dealing with feeling tired" , exceeding those has an unmet need in "dealing with not feeling sure that the cancer has gone" or "being told they had cancer".

Studies in solid cancer suggests that methylphenidat (MTP) may 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. Patients are randomized to treatment with MTP or placebo week 1-6 followed by a 1-week "wash-out" and subsequent 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 (endurance and strength), and QoL. The study forms a basis for future research and advances in the field of supportive and palliative care in haematology in Denmark and may facilitate CRF handling.

Description of the cohort

Adult patients with haematological cancer and defined fatigue thresholds. Patient in current chemotherapy and patients with severe anemia are not included. 

Data and biological material

Questionnaires