Prostate Cancer Clinical Trial
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | August 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 90 Years |
Eligibility |
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 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. 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Fordham University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To study the efficacy of methylphenidate (Ritalin) versus placebo in the treatment of fatigue in ambulatory men with prostate cancer | |||
Secondary | To study the frequency and severity of adverse side effects associated with this psychostimulant drug | |||
Secondary | To study the effects of psychostimulant treatment for fatigue on related domains of psychosocial function and quality of life |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |