Psychostimulants for Fatigue in Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00138138|
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : December 10, 2007
Fatigue is one of the most common symptoms of prostate cancer. Fatigue is a lack of energy that makes it harder to do the things you normally do every day. Some symptoms of fatigue are:
- feeling tired and/or weak;
- having less interest in activities;
- having trouble concentrating;
- feeling "down";
- feeling exhausted for no clear reason.
There are not many drugs that are helpful in treating fatigue. However, one group of medications does seem to be useful. In this study, we, the investigators at Memorial Sloan-Kettering Cancer Center, will be using a psychostimulant called Ritalin. The aim of this study is to see if this drug is helpful in treating fatigue in prostate cancer. We are also studying the side effects of this medication.
|Condition or disease||Intervention/treatment||Phase|
|Fatigue Prostate Cancer||Drug: Ritalin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Psychostimulants for Fatigue in Advanced Prostate Cancer|
|Study Start Date :||October 2002|
|Study Completion Date :||August 2006|
- To study the efficacy of methylphenidate (Ritalin) versus 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138138
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Andrew Roth, M.D||Memorial Sloan Kettering Cancer Center|