Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

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: 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

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

No publications provided

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

Keywords provided by University Health Network, Toronto:

LHRH-agonist related fatigue

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 08, 2010