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

Phase 2
18 Years
85 Years
Not Enrolling
Prostatic Neoplasms, Fatigue

Thank you

Trial Information

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

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

Inclusion Criteria


- 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.


- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome 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).

Outcome Time Frame:

3 months pre-treatment (LHRH-agnost naive group only), randomization, 6 weeks, 10 weeks, 12 weeks, 24 weeks

Safety Issue:


Principal Investigator

Neil E Fleshner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Health Canada

Study ID:




Start Date:

January 2008

Completion Date:

May 2011

Related Keywords:

  • Prostatic Neoplasms
  • Fatigue
  • LHRH-agonist related fatigue
  • Neoplasms
  • Fatigue
  • Prostatic Neoplasms