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

University Health Network, Toronto

Status and phase

Terminated

Phase 2

Conditions

Prostatic Neoplasms

Fatigue

Treatments

Drug: Matched Placebo

Drug: Methylphenidate Hydrochloride

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00593853

LEUPR_L_01

07-0350-C

Details and patient eligibility

About

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

Full description

This study will determine if methylphenidate improves fatigue in men undergoing hormonal therapy for prostate cancer. Fatigue is a common problem experienced by cancer patients. Those patients who are receiving chemotherapy or radiation are especially vulnerable to fatigue, as are men with prostate cancer who are receiving hormonal therapy with an LHRH-agonist (androgen deprivation therapy). Eligible men will be randomized to a daily dose of 10 mg methylphenidate or placebo for a total treatment period of 12 weeks. Subjects will be monitored for changes in fatigue and mood during this period. While the exact cause of fatigue in this setting is unknown, this study will hopefully lead to a better understanding of the process and provide patients with a much-needed remedy for fatigue

Enrollment

33 patients

Sex

Male

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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