Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
Prostate Carcinoma
About this trial
This is an interventional supportive care trial for Prostate Carcinoma
Eligibility 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 </=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 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).
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Active Comparator
Active Comparator
Group I (methylphenidate, resistance training, walking)
Group II (placebo, resistance training, stretching)
Group III (methylphenidate, stretching)
Group IV (placebo, stretching)
Patients receive methylphenidate PO BID and undergo exercise program consisting of resistance training BIW and walking 15- 40 minutes a day 4 days a week for 12 weeks.
Patients receive a placebo PO BID and undergo exercise program consisting of resistance training BIW and walking 15-40 minutes a day for 4 days a week for 12 weeks.
Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.
Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.