Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy

Prior treatment

• Be currently taking MP or have taken it within the previous 10 days.
• Regularly used cognitive behavioral therapy in the last 6 weeks.
• Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine.
• Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).

Other illness

• Have a major contraindication to MP (e.g., allergy/hypersensitivity to study medications or their constituents), exercise (e.g., cardiac disease), cognitive behavioral therapy (e.g., schizophrenia), or conditions making adherence difficult as determined by the attending physician.
• Have with history of severe cardiac disease (New York Heart Association functional class III or IV).
• Have tachycardia and/or uncontrolled hypertension
• History of uncontrolled hypothyroidism as evidenced by thyroid test (TSH) within the last month, hypercalcemia or hyperglycemia (within the last 15 days).
• Any medical or psychological condition or any reason that, according to the investigator's judgment, makes the patient unsuitable for participation in the study.

Other

• Are regularly engaged in moderate- or vigorous-intensity exercise for at least 150 minutes per week.
• Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.
• Have glaucoma.
• Unable to speak and understand English

• Have a diagnosis of prostate cancer and are scheduled to receive radiotherapy with androgen deprivation therapy
• Rate fatigue at least 1 or higher on a scale of 0-10.
• Describe fatigue as being present every day for most of day for a minimum of 2 weeks.
• Have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale (MDAS) score of \</=13 at baseline.
• Be aged 18 years or older.
• Be willing to engage in follow-up telephone calls with a research nurse/coordinator.
• Be willing to participate in the exercise and in Cognitive Behavioral Therapy (CBT).
• Have telephone access to be contacted by the research nurse/coordinator.
• 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 of 0 to 2.