Modafinil in der Behandlung von Müdigkeit bei Tumorpatienten - eine randomisierte doppelblinde N=1 Studie - Modafinil for treatment of fatigue in cancer patients
- Conditions
- advanced cancer disease
- Registration Number
- EUCTR2005-002699-13-DE
- Lead Sponsor
- Department of Palliative Medicine, RWTH Aachen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
patients with advanced cancer
treated in the paliative care unit
palliative prognostic index <= 6 (indicating high probability of survival >= 3 weeks
severe fatigue on a 4-step categorical scale for self-assessment of the patient
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
nonmalignant disease
patients not able to complete self-assessment
palliative prognostic index >6
patient refuses to participate
pregnancy or lactation
impaired organ function from liver, renal or cardiac disease or hypertonus that does not allow treatment with modafinil in the opinion of the investigator
investigator finds burden for the patient to high
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method