Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Prostate Carcinoma

In brief

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 stimulant that can improve cognitive ability, mainly in memory and cognitive function. Exercise can improve mood and the physical aspects of cancer-related fatigue. Giving methylphenidate in combination with exercise may work better in reducing cancer-related fatigue in patients with prostate cancer.

Key facts

Study ID

NCT03772834

Run by

M.D. Anderson Cancer Center

People needed

200

Starts

2019-03-25

Expected to finish

2026-11-30

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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).

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.