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

Condition(s) targeted: Prostatic Neoplasms; Fatigue

Intervention: Methylphenidate Hydrochloride (Drug); Matched Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University Health Network, Toronto

Official(s) and/or principal investigator(s):
Neil E Fleshner, MD, Principal Investigator, Affiliation: University Health Network, Toronto
Shabbir MH Alibhai, MD, Principal Investigator, Affiliation: University Health Network, Toronto

Overall contact:
Meerna Khatcherian, BSc, Phone: 416-946-4501, Ext: 3832, Email: Meerna.Khatcherian@uhn.on.ca

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

Official title: A Phase II, Randomized, Double-Blind, Placebo Controlled Trial of Methylphenidate Hydrochloride for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH-Agonist Therapy

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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).

Secondary outcome:

Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Bruera Global Fatigue Severity Scale

Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Centre for Epidemiological Studies Depression Scale(CESD)

Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Medical Outcomes Study 36-Item Short Form (SF-36)

Detailed 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

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Male.

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

Meerna Khatcherian, BSc, Phone: 416-946-4501, Ext: 3832, Email: Meerna.Khatcherian@uhn.on.ca

UHN Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada; Recruiting
Neil E Fleshner, MD, Principal Investigator

Starting date: January 2008
Ending date: January 2010
Last updated: February 12, 2009