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| Sponsor: | University Health Network, Toronto |
|---|---|
| Collaborator: |
Sanofi-Aventis |
| Information provided by: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00593853 |
Purpose
The purpose of this study is to determine if methylphenidate improves fatigue in men undergoing hormonal therapy for prostate cancer with an LHRH-agonist.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostatic Neoplasms Fatigue |
Drug: Methylphenidate Hydrochloride Drug: Matched Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II, Randomized, Double-Blind, Placebo Controlled Trial of Methylphenidate Hydrochloride for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH-Agonist Therapy |
| Estimated Enrollment: | 128 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: Methylphenidate Hydrochloride
Run in period of 5mg QD,PO for 2 weeks followed by 5mg BID,PO for 8 weeks (full daily dose of 10mg). Followed by a 2 week taper period of 5mg QD,PO to complete 12 week cycle.
|
| 2: Placebo Comparator |
Drug: Matched Placebo
Run in period of 5mg QD,PO for 2 weeks followed by 5mg BID,PO for 8 weeks (full daily dose of 10mg). Followed by a 2 week taper period of 5mg QD,PO to complete 12 week cycle.
|
This study will determine if methylphenidate improves fatigue in men undergoing hormonal therapy for prostate cancer. Fatigue is a common problem experienced by cancer patients. Those patients who are receiving chemotherapy or radiation are especially vulnerable to fatigue, as are men with prostate cancer who are receiving hormonal therapy with an LHRH-agonist (androgen deprivation therapy). Eligible men will be randomized to a daily dose of 10 mg methylphenidate or placebo for a total treatment period of 12 weeks. Subjects will be monitored for changes in fatigue and mood during this period. While the exact cause of fatigue in this setting is unknown, this study will hopefully lead to a better understanding of the process and provide patients with a much-needed remedy for fatigue
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contacts and Locations| Contact: Meerna Khatcherian, BSc | 416-946-4501 ext 3832 | Meerna.Khatcherian@uhn.on.ca |
| Contact: Karen Hersey, R.N | 416-946-4501 ext 2155 | karen.hersey@uhn.on.ca |
| Canada, Ontario | |
| UHN Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Principal Investigator: Neil E Fleshner, MD | |
| Principal Investigator: | Neil E Fleshner, MD | University Health Network, Toronto |
| Principal Investigator: | Shabbir MH Alibhai, MD | University Health Network, Toronto |
More Information
| Responsible Party: | University Health Network, Toronto ( Dr. Neil Fleshner, MD, MPH, FRCSC ) |
| Study ID Numbers: | LEUPR_L_01, 07-0350-C |
| Study First Received: | January 3, 2008 |
| Last Updated: | February 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00593853 History of Changes |
| Health Authority: | Canada: Health Canada |
|
LHRH-agonist related fatigue |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Fatigue Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Physiological Effects of Drugs Methylphenidate Central Nervous System Stimulants |
Urogenital Neoplasms Genital Diseases, Male Pharmacologic Actions Signs and Symptoms Neoplasms Neoplasms by Site Therapeutic Uses Dopamine Agents Central Nervous System Agents Prostatic Neoplasms |