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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Terminated
CT.gov ID
NCT00593853
Collaborator
Sanofi (Industry)
33
Enrollment
1
Location
2
Arms
40
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Methylphenidate Hydrochloride
  • Drug: Matched Placebo
 Phase 2

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

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
May 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

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.
Other Names:
  • Ritalin

    		•
    Placebo Comparator: 2

    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.
    Other Names:
  • Inert Filler (lactose)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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). [3 months pre-treatment (LHRH-agnost naive group only), randomization, 6 weeks, 10 weeks, 12 weeks, 24 weeks]

    Secondary Outcome Measures

    1. Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Bruera Global Fatigue Severity Scale [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]

    2. Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Centre for Epidemiological Studies Depression Scale(CESD) [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]

    3. Reduction in LHRH-agonist-related fatigue in prostate cancer patients as measured by the Medical Outcomes Study 36-Item Short Form (SF-36) [3 months pre-treatment (LHRH-agonist naive group only), Randomization, 6 weeks, 10 weeks, 24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    • Evidence of drug or alcohol abuse

    • Known hypersensitivity to methylphenidate

    • Possess any other contraindications to methylphenidate use

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UHN Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • University Health Network, Toronto
    • Sanofi

    Investigators

    • Principal Investigator: Neil E Fleshner, MD, University Health Network, Toronto
    • Principal Investigator: Shabbir MH Alibhai, MD, University Health Network, Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Neil Fleshner, MD, MPH, FRCSC, University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT00593853
    Other Study ID Numbers:
    • LEUPR_L_01
    • 07-0350-C
    First Posted:
    Jan 15, 2008
    Last Update Posted:
    Jun 4, 2014
    Last Verified:
    Jun 1, 2014
    Keywords provided by Dr. Neil Fleshner, MD, MPH, FRCSC, University Health Network, Toronto
    LHRH-agonist related fatigue
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Fatigue
    Methylphenidate

    Study Results

    No Results Posted as of Jun 4, 2014