Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine if methylphenidate improves fatigue in men undergoing hormonal therapy for prostate cancer with an LHRH-agonist.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Sanofi
• Treatments: Methylphenidate

Criteria

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