FatiguePhase 2NCT00138138
Psychostimulants for Fatigue in Prostate Cancer
A Phase 2 study testing Ritalin in people with Fatigue and Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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 and/or weak; having less interest in activities; having trouble concentrating; feeling "down"; feeling exhausted for no… Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Fatigue, Prostate Cancer
- What is being tested?
- Ritalin
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Aug 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 study.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Psychostimulants for Fatigue in Advanced Prostate Cancer
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.
Read the 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.
- Conditions
- Fatigue, Prostate Cancer
- Being tested
- Ritalin
- Medical subject headings
- Fatigue, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitalinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the efficacy of methylphenidate (Ritalin) versus placebo in the treatment of fatigue in ambulatory men with prostate cancer
Secondary outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startOct 2002
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fordham University
- Investigators
- Andrew Roth, M.D, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138138
- Sponsor's protocol ID
- 02-100
- Status last verified
- Dec 2007
- First submitted
- 26 Aug 2005
- Last updated
- 10 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychostimulants for Fatigue in Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT00138138
- Acronym / sponsor ID
- 02-100
- Conditions
- Fatigue, Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Fordham University
- Study start
- Oct 2002
- Study completion
- Aug 2006 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 study.
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ritalin | Drug | – |
Primary outcome
To study the efficacy of methylphenidate (Ritalin) versus placebo in the treatment of fatigue in ambulatory men with prostate cancer
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2007.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Roth, M.D principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ritalin in people with Fatigue and Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the efficacy of methylphenidate (Ritalin) versus placebo in the treatment of fatigue in ambulatory men with prostate cancer. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2007.