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Psychostimulants for Fatigue in Advanced Prostate Cancer

Phase 2
40 Years
90 Years
Not Enrolling
Fatigue, Prostate Cancer

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Trial Information

Psychostimulants for Fatigue in Advanced Prostate Cancer

This study is open to men who have prostate cancer and report feeling fatigue. We will
examine the impact of psychostimulant treatment on depressive symptom severity,
neuropsychological test performance, and overall quality of life, as well as compare the
frequency and severity of treatment associated adverse side effects. We will be conducting a
six-week, randomized, double-blind, placebo-controlled, parallel design trial, evaluating
the relative benefits and risks of methylphenidate, (a psychostimulant medication).
Medication will be given in once or twice daily dosages (at 8 am and noon) and titrated by
one capsule every 2-3 days as needed to treat fatigue and as tolerated. Patients will be
examined regularly for safety. We will monitor vital signs and response to the medication.
This study will be the first of its kind to evaluate a pharmacologic intervention for
fatigue in cancer patients that utilizes a novel psychotropic agent (psychostimulant), and
assesses outcome with measures of fatigue, as well as side effects, psychological distress,
depression and overall quality of life.

Objectives: To study the efficacy of methylphenidate vs. placebo in the treatment of fatigue
in ambulatory men with prostate cancer.

To study the frequency and severity of adverse side effects associated with this
psychostimulant drug.

To study the effects of psychostimulant treatment for fatigue on related domains of
psychosocial function and quality of life.

Inclusion Criteria:

- 18 years of age or older and English speaking (patients who cannot read will be
offered assistance with the consent forms and surveys). There is no maximum age cut
off for eligibility into this study.

- Diagnosed with prostate cancer.

- Receiving ambulatory medical care at the time of initial assessment and primary
treating physician is aware of and agrees to the subject's participation in the

- Fatigue that has been persistent (chronic-recurrent or continuous for a period of at
least 2 weeks), and is reported to have an intensity of moderate or severe (a score
of 4 or greater on one question that assesses fatigue over a two week period on a
0-10 numeric rating scale).

- Patients who have already received six weeks of Procrit therapy at 60,000 units for
anemia and still have significant fatigue will then become eligible for this
stimulant trial.

- Patients who have received three weeks of thyroid supplementation therapy for
hypothyroidism and still have significant fatigue will then become eligible for this
stimulant trial.

- Patients who are able to give informed consent.

Exclusion Criteria:

- Significant cognitive impairment (Mini-Mental Status score of 22 or below) or
psychiatric disturbance sufficient, in the investigator's judgment, to preclude data
collection and informed consent.

- Evidence of severe renal or hepatic disease; serum creatinine and liver function
tests (LFT's) must be no higher than 2 times the upper limit of normal.

- A white blood cell count below 2,000 cells per cubic millimeter or platelets 60,000
per cubic millimeter or less.

- Uncontrolled hypertension (blood pressure [BP] of 170/100 or greater) will exclude
patients from the study. For those patients with histories of controlled
hypertension (either by diet or medication), methylphenidate may increase resting
blood pressure by 5 mmHg. (The patients will have blood pressure, pulse and other
vital signs monitored weekly under the auspices of the Genitourinary Clinic, or at
home under the instruction of the research nurse, using a blood pressure monitor
issued by the study.)

- Urgent need of a primary medical therapy for fatigue that would be more appropriate
than the study drug (eg, severe anemia where the hemoglobin is less than 11.0 or if
the patient is symptomatic. Patients who have already received six weeks of Procrit
therapy and still have significant fatigue will then become eligible for this trial).

- Patients found to have significant hypothyroidism (as defined by thyroid stimulating
hormone test greater than 4.42 upon blood chemistry screening), will be ineligible
for this study until they have completed three weeks of appropriate thyroid
supplementation and are still found to exhibit significant fatigue.

- History of substance abuse (ie, stimulant drugs, cocaine, or injection drug use) or
participation in a methadone maintenance program. Patients with a history of alcohol
abuse will not be excluded from this study if they are currently not abusing alcohol.

- Meeting criteria for a diagnosis of major depressive episode - current (screening for
major depression will be completed using the Structured Clinical Interview for
DSM-IIIR, Nonpatient Version [SCID-NP]). Concurrent use of monoamine oxidase (MAO)
inhibitors, tricyclic antidepressants, or a psychostimulant will exclude subjects
from study participation. Concurrent use of other antidepressant medications (eg,
selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake
inhibitors [SNRIs]) will not exclude subjects from study participation.

- History of allergy to, or intolerance of, methylphenidate.

- Karnofsky Patient Performance Rating score of 50 or below.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

To study the efficacy of methylphenidate (Ritalin) versus placebo in the treatment of fatigue in ambulatory men with prostate cancer

Principal Investigator

Andrew Roth, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2002

Completion Date:

August 2006

Related Keywords:

  • Fatigue
  • Prostate Cancer
  • Fatigue
  • Prostatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021