NCT00758407
Completed
Phase 2
Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue
ConditionsCancer-related Fatigue
Overview
- Phase
- Phase 2
- Intervention
- Methylphenidate hydrochloride
- Conditions
- Cancer-related Fatigue
- Sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
- Enrollment
- 66
- Locations
- 6
- Primary Endpoint
- General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •history of Cancer
- •Karnofsky Index \>=70
- •outpatient
- •patient are able to give informed consent
Exclusion Criteria
- •treatment with psychostimulants in the past two weeks before screening
- •active tumor disease
- •depression (HADS \>10)
- •cachexia (BMI \<18kg/m2)
- •clinically relevant kidney disorders
- •clinically relevant liver disorder
- •pathological ECG-finding
- •high blood pressure
- •occlusive arterial disease
- •angina pectoris
Arms & Interventions
1
Intervention: Methylphenidate hydrochloride
2
Intervention: Placebo
Outcomes
Primary Outcomes
General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)
Time Frame: 6 weeks
Secondary Outcomes
- Quality of Life (EORTC-QLQ C30)(6 weeks)
Study Sites (6)
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