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

• Status: Recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: Male

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 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• 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
• 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 Criteria:

• 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).