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Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy

This study is currently recruiting participants.
Verified by University Health Network, Toronto, January 2008

Sponsors and Collaborators: University Health Network, Toronto
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

MedlinePlus related topics:   Cancer   Prostate Cancer  

ChemIDplus related topics:   Methylphenidate hydrochloride   Methylphenidate   Lactose   Gonadorelin   Gonadorelin hydrochloride   LH-RH  

U.S. FDA Resources

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

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To assess the ability of methylphenidate 5 mg BID (10 mg daily) to reduce LHRH-agonist-related fatigue in prostate cancer patients as measured by the Functional Assessment of Cancer Therapy Fatigue subscale (FACT-F). [ Time Frame: 3 months pre-treatment (LHRH-agnost naive group only), randomization, 6 weeks, 10 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Bruera Global Fatigue Severity Scale [ Time Frame: Screening Visit 1, 3 months pre-treatment (LHRH-agonist naive group only), Screening Visit 2 (LHRH-agonist naive group only), Randomization, 2 weeks, 6 weeks, 10 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Centre for Epidemiological Studies Depression Scale(CESD) [ Time Frame: Screening Visit 1, 3 months pre-treatment (LHRH-agonist naive group only), Screening Visit 2 (LHRH-agonist naive group only), Randomization, 6 weeks, 10 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Medical Outcomes Study 36-Item Short Form (SF-36) [ Time Frame: 3 months pre-treatment (LHRH-agonist naive group only), Randomization, 6 weeks, 10 weeks, 24 weeks ] [ Designated as safety issue: No ]

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.

Detailed Description:

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

Criteria

Inclusion:

  • Age > 18 and ≤ 85 years
  • Histologically confirmed prostate cancer
  • Currently receiving LHRH-agonist therapy for greater than 6 months with measurable fatigue, defined as a score of >1 on the Bruera global fatigue severity scale OR
  • Deemed eligible to commence LHRH-agonist therapy, with confirmation of fatigue at Screening Visit 2
  • Have a serum PSA which is stable or decreasing based on the PSA trend over the last 2 values taken at least 2 months apart, with the more recent value taken at least 2 months after initiation of LHRH-agonist therapy.
  • Have adequate liver and renal function (Bilirubin ≤ 1.5 x ULN and AST, ALT and Serum Creatinine < 2 x ULN)
  • Able to swallow and retain oral medication
  • Life expectancy of at least 1 year
  • Able to read and write in English (and therefore accurately complete the required study questionnaires), understand instructions related to study procedures and give written informed consent.

Exclusion:

  • Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (other exceptions are superficial bladder cancer or non-melanoma skin cancer)
  • Previous chemotherapy within the last 5 years
  • Anemia (Hemoglobin < 100 g/L)
  • Myocardial infarction within past 6 months
  • Any unstable serious co-existing medical condition(s) including but not limited to ; unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, Severe bleeding diseases or immune disorders
  • Severe depression as defined by CES-D score >27
  • History of motor tics, seizures or a family history of Tourette's syndrome
  • Infection with HIV (Human Immunodeficiency Virus), HBV (Hepatitis B) or HCV (Hepatitis C)
  • Evidence of drug or alcohol abuse
  • Known hypersensitivity to methylphenidate
  • Possess any other contraindications to methylphenidate use
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593853

Contacts
Contact: Kelly M Caetano, BHSc     416-946-4501 ext 3141     kelly.caetano@uhn.on.ca    
Contact: Karen Hersey, R.N     416-946-4501 ext 2155     karen.hersey@uhn.on.ca    

Locations
Canada, Ontario
UHN Princess Margaret Hospital     Recruiting
      Toronto, Ontario, Canada, M5G 2M9
      Principal Investigator: Neil E Fleshner, MD            

Sponsors and Collaborators
University Health Network, Toronto
Sanofi-Aventis

Investigators
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
First Received:   January 3, 2008
Last Updated:   January 14, 2008
ClinicalTrials.gov Identifier:   NCT00593853
Health Authority:   Canada: Health Canada

Keywords provided by University Health Network, Toronto:
LHRH-agonist related fatigue  

Study placed in the following topic categories:
Dopamine
Fatigue
Prostatic Diseases
Genital Neoplasms, Male
Methylphenidate
Urogenital Neoplasms
Prostatic Neoplasms

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Stimulants
Genital Diseases, Male
Pharmacologic Actions
Signs and Symptoms
Neoplasms
Neoplasms by Site
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 03, 2008




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