Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138138
Status:
COMPLETED
Last Update Posted:
2007-12-10
First Post:
2005-08-26
Brief Title:
Psychostimulants for Fatigue in Prostate Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Psychostimulants for Fatigue in Advanced Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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
feeling tired andor 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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None