Clinical trial · Interventional
Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy
A Phase II, Randomized, Double-blind, Placebo Controlled Trial of Methylphenidate Hydrochloride for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH-Agonist Therapy
NCT00593853CI-TRIAL-00014776terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine if methylphenidate improves fatigue in men undergoing hormonal therapy for prostate cancer with an LHRH-agonist.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Matched Placebo | Drug | — | UNRESOLVED |
| Methylphenidate Hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Drug: Methylphenidate Hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- 2
- interventionNames
- Drug: Matched Placebo
Primary outcomes (1)
- measure
- To assess the ability of methylphenidate 5 mg BID (10 mg daily) to reduce LHRH-agonist-related fatigue in prostate cancer patients as measured by the Functional Assessment of Cancer Therapy Fatigue subscale (FACT-F).
- timeFrame
- 3 months pre-treatment (LHRH-agnost naive group only), randomization, 6 weeks, 10 weeks, 12 weeks, 24 weeks
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion: * Age \> 18 and ≤ 85 years * Histologically confirmed prostate cancer * Currently receiving LHRH-agonist therapy for greater than 6 months with measurable fatigue, defined as a score of \>1 on the Bruera global fatigue severity scale OR * Deemed eligible to commence LHRH-agonist therapy, with confirmation of fatigue at Screening Visit 2 * Have a serum PSA which is stable or decreasing based on the PSA trend over the last 2 values taken at least 2 months apart, with the more recent value taken at least 2 months after initiation of LHRH-agonist therapy. * Have adequate liver and renal function (Bilirubin ≤ 1.5 x ULN and AST, ALT and Serum Creatinine \< 2 x ULN) * Able to swallow and retain oral medication * Life expectancy of at least 1 year * Able to read and write in English (and therefore accurately complete the required study questionnaires), understand instructions related to study procedures and give written informed consent. Exclusion: * Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (other exceptions are superficial bladder cancer or non-melanoma skin cancer) * Previous chemotherapy within the last 5 years * Anemia (Hemoglobin \< 100 g/L) * Myocardial infarction within past 6 months * Any unstable serious co-existing medical condition(s) including but not limited to ; unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, Severe bleeding diseases or immune disorders * Severe depression as defined by CES-D score \>27 * History of motor tics, seizures or a family history of Tourette's syndrome * Infection with HIV (Human Immunodeficiency Virus), HBV (Hepatitis B) or HCV (Hepatitis C) * Evidence of drug or alcohol abuse * Known hypersensitivity to methylphenidate * Possess any other contraindications to methylphenidate use
References
Publications (1)
- RESULTRichard PO, Fleshner NE, Bhatt JR, Hersey KM, Chahin R, Alibhai SM. Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy. BJU Int. 2015 Nov;116(5):744-52. doi: 10.1111/bju.12755. Epub 2015 Jun 8. PMID 24684534