Cognitive Behavioral Therapy, Exercise, and Methylphenidate Hydrochloride in Reducing Fatigue in Patients with Prostate Cancer Receiving Radiation Therapy

Status: closed to accrual

This randomized phase II trial studies how well cognitive behavioral therapy, exercise, and methylphenidate hydrochloride work in reducing fatigue in patients with prostate cancer. Cognitive behavioral therapy is a type of psychotherapy that helps patients change their behavior by changing the way they think and feel about certain things. Exercises and physical activities help condition muscles and restore strength and movement. Methylphenidate hydrochloride acts on certain parts of the brain and may help reduce anxiety and depressive mood. Cognitive behavioral therapy, exercise, and methylphenidate hydrochloride may help relieve fatigue in patients with prostate cancer receiving radiation therapy.

Inclusion Criteria

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 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

Exclusion Criteria

Have a major contraindication to methylphenidate hydrochloride (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
Be currently taking MP or have taken it within the previous 10 days
Are regularly engaged in moderate- or vigorous-intensity exercise for at least 150 minutes per week
Regularly used cognitive behavioral therapy in the last 6 weeks
Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study
Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine
Have glaucoma
Have with history of severe cardiac disease (New York Heart Association functional class III or IV)
Have tachycardia and/or uncontrolled hypertension
Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine)
History of uncontrolled hypothyroidism as evidenced by thyroid test (thyroid-stimulating hormone [TSH]) within the last month, hypercalcemia or hyperglycemia (within the last 15 days)
Unable to speak and understand English
Any medical or psychological condition or any reason that, according to the investigator’s judgment, makes the patient unsuitable for participation in the study

PRIMARY OBJECTIVES:

I. To obtain preliminary estimates of the effects of various treatments (exercise, cognitive behavioral therapy [CBT], methylphenidate [methylphenidate hydrochloride]) and combinations of treatments in multimodal therapy (MMT) in reducing cancer-related fatigue in patients with prostate cancer receiving radiotherapy (RT), as measured by area under the curve (AUC) of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale scores taken at baseline, day 15, day 29 and on day 57 (+/- 2 weeks).

SECONDARY OBJECTIVES:

I. To explore the effect of MMT on anxiety (Hospital Anxiety Depression Scale [HADS]), depressed mood (HADS), physical activity (accelerometer), and function (handgrip dynamometer) and on levels of inflammatory cytokines (interleukin [IL]-1beta, IL-1 receptor alpha [RA], IL-6, IL-8, IL-10, and tumor necrosis factor [TNF]- and receptors TNF receptor [R]1 and 2) on serum and induced monocytes, before and after treatment with various fatigue treatment combinations of MMT.

II. To determine the safety of MMT (type, frequency, and severity of the adverse events).

OUTLINE: Patients are randomized to 1 of 8 treatment arms.

ARM I: Patients receive methylphenidate hydrochloride orally (PO) twice daily (BID), engage in resistance exercise and walking, and receive cognitive behavioral therapy over 30 minutes for 6-7 sessions.

ARM II: Patients receive methylphenidate hydrochloride PO BID, engage in resistance exercise and walking, and receive standard supportive counseling over 30 minutes for 6-7 sessions.

ARM III: Patients receive methylphenidate hydrochloride PO BID, engage in stretching exercise, and receive cognitive behavioral therapy over 30 minutes for 6-7 sessions.

ARM IV: Patients receive methylphenidate hydrochloride PO BID, engage in stretching exercise, and receive standard supportive counseling over 30 minutes for 6-7 sessions.

ARM V: Patients receive placebo PO BID, engage in resistance exercise and walking, and receive cognitive behavioral therapy over 30 minutes for 6-7 sessions.

ARM VI: Patients receive placebo PO BID, engage in resistance exercise and walking, and receive standard supportive counseling over 30 minutes for 6-7 sessions.

ARM VII: Patients receive placebo PO BID, engage in stretching exercise, and receive cognitive behavioral therapy over 30 minutes for 6-7 sessions.

ARM VIII: Patients receive placebo PO BID, engage in stretching exercise, and receive standard supportive counseling over 30 minutes for 6-7 sessions.

In all arms, treatment continues for up to 57 days (+/- 2 weeks) in the absence of disease progression or unacceptable toxicity.

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

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Cognitive Behavioral Therapy, Exercise, and Methylphenidate Hydrochloride in Reducing Fatigue in Patients with Prostate Cancer Receiving Radiation Therapy

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