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MethylphenIdate for Fatigue in Haematological Cancer

NCT03218254 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-12-05

No results posted yet for this study

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.

Conditions

  • Hematological Cancer

Interventions

DRUG

Methylphenidate

Titration of MTP for treatment of fatigue

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Henrik Frederiksen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-08
Primary Completion
2021-10-01
Completion
2021-10-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03218254 on ClinicalTrials.gov