Clinical trial · Interventional
Methylphenidate Treatment of Cancer-Related Fatigue
Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue
NCT00758407CI-TRIAL-00003014EMFcompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylphenidate hydrochloride | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Drug: Methylphenidate hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- 2
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)
- timeFrame
- 6 weeks
Secondary outcomes (1)
- measure
- Quality of Life (EORTC-QLQ C30)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * history of Cancer * MFI \>40 * 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 * cardiac arrhythmias * CHD * post heart-attack status * post stroke status * known elevated intra-ocular pressure * known enlarged prostates * latent and manifest hyperthyreosis * alcohol, medication or drug dependency in the past six months or manifest drug abuse * participation in a clinical study within the past 30 days * participation in this study at an earlier point in time * simultaneous participation in another clinical trial * women of child-bearing age without adequate contraception (contraceptives, intrauterine device , no sexual intercourse) * pregnancy (positive pregnancy test) or lactation period
References
Publications (0)
Data not yet available
No reference posted for this study.