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

NCT ID: NCT00593853

Last Updated: 2014-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-05-31

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.

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

Conditions

Prostatic Neoplasms; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Methylphenidate Hydrochloride

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Matched Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Ritalin; Inert Filler (lactose)

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Dr. Neil Fleshner

MD, MPH, FRCSC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neil E Fleshner, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Shabbir MH Alibhai, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

UHN Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Richard PO, Fleshner NE, Bhatt JR, Hersey KM, Chahin R, Alibhai SM. Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy. BJU Int. 2015 Nov;116(5):744-52. doi: 10.1111/bju.12755. Epub 2015 Jun 8.

Reference Type: RESULT

PMID: 24684534 (View on PubMed)

Other Identifiers

07-0350-C

Identifier Type: -

Identifier Source: secondary_id

LEUPR_L_01

Identifier Type: -

Identifier Source: org_study_id