Status:
ACTIVE_NOT_RECRUITING
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This phase II/III trial studies how well methylphenidate and exercise work in reducing cancer-related fatigue in patients with prostate cancer. Methylphenidate is a type of central nervous system stim...
Detailed Description
PRIMARY OBJECTIVE: I. To determine if the combination of exercise (EX) plus methylphenidate (MP) is superior to exercise plus placebo in the treatment of cancer-related fatigue (CRF) in patients with...
Eligibility Criteria
Inclusion
- Have a diagnosis of prostate cancer and be scheduled to receive radiotherapy with concurrent androgen deprivation therapy, and presence of fatigue with severity of 1/10, on a 0-10 scale for at least 2 weeks
- Patient not regularly engaging in moderate aerobic exercise for \>90 minutes/week and/or vigorous aerobic exercise for \>30 minutes/week, and/ or strength training for \>/= 1 day/week
- Have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of \</=13 at baseline
- Be aged 18 years or older
- Be willing to engage in follow-up telephone calls with a research staff
- Be willing to participate in the exercise programs
- Have telephone access so they can be contacted by the research staff
- Have a hemoglobin level of \>/= 10 g/dL within 2 weeks of enrollment
- Be able to understand the description of the study and give written informed consent
- Have a Zubrod performance status score of 0 to 2
- Seen at an outpatient clinic at MD Anderson Cancer Center, its Houston Area Locations (HALs) or Smith Radiation Oncology Clinic (HHS)
Exclusion
- Have a major contraindication to MethylphenidateMP) (e.g., allergy/hypersensitivity to study medications or their constituents), exercise (e.g., cardiac disease), or conditions making adherence difficult as determined by the attending physician
- Be currently taking MP, or have taken it within the previous 10 days
- Be unable to complete the baseline assessment forms (e.g., due to language or sensory barriers) or to understand the recommendations for participation in the study
- Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine
- Have glaucoma
- Have severe cardiac disease (New York Heart Association functional class III or IV)
- Have tachycardia and/or uncontrolled hypertension
- Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantone, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03772834
Start Date
March 25 2019
End Date
November 30 2026
Last Update
October 10 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030