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

This study has been terminated.
(Slow Accrual)
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Dr. Neil Fleshner, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00593853
First received: January 3, 2008
Last updated: June 3, 2014
Last verified: June 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ]

Enrollment: 33
Study Start Date: January 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Inert Filler (lactose)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
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
  More Information

Publications:
Responsible Party: Dr. Neil Fleshner, MD, MPH, FRCSC, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00593853     History of Changes
Other Study ID Numbers: LEUPR_L_01, 07-0350-C
Study First Received: January 3, 2008
Last Updated: June 3, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 19, 2014