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

PRIMARY OBJECTIVES:

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
prostate cancer scheduled to receive radiotherapy with androgen deprivation therapy for 12
weeks.

SECONDARY OBJECTIVES:

I. To determine the effects of combined exercise plus methylphenidate on quality-of-life,
mood, physical, and cognitive measures.

EXPLORATORY OBJECTIVES:

I. To identify potential synergistic effects of exercise and methylphenidate in improvement
of CRF.

II. To explore changes in brain activity by electroencephalography (EEG) in responders (with
4 point or greater change in Functional Assessment of Chronic Illness Therapy-Fatigue
[FACIT-F] scores) versus (vs) non-responders to the intervention.

OUTLINE: Patients are randomized to 1 of 4 groups.

GROUP I: Patients receive methylphenidate orally (PO) twice daily (BID) and undergo exercise
program consisting of resistance training twice weekly (BIW) and walking 15- 40 minutes a day
4 days a week for 12 weeks.

GROUP II: 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.

GROUP III: Patients receive methylphenidate PO BID and undergo stretching for 4 days a week
for 12 weeks.

GROUP IV: Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12
weeks.

After completion of study treatment, patients are followed up at 3 months.

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
3/10, 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 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 regional cancer centers
or Lyndon B. Johnson (LBJ) Hospital Radiation Oncology Clinic

Exclusion Criteria:

- Have a major contraindication to methylphenidate (MP) (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)