advanced cancer disease
Conditions
Interventions
Trade Name: Vigil
Product Name: Modafinil
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
Department of Palliative Medicine, RWTH Aachen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients with advanced cancer treated in the paliative care unit palliative prognostic index = 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: efficacy according to self-assessment of modafinil in the treatment of cancer-related sedation and fatigue;Secondary Objective: efficacy according to staff-assessment and tolerability of modafinil in cancer-related sedation and fatigue;Primary end point(s): sum score of sedation intensity on six treatment days with modafinil compared to sum score of sedation intensity on six treatment days with placebo | — |
Countries
Germany
Outcome results
None listed