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

• Status: Active, not recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The goal of this clinical research study is to learn about the effect of different combinations of exercise, supportive counseling, and methylphenidate/placebo for the treatment of fatigue in patients with prostate cancer. The safety of this treatment combination will also be studied.

Methylphenidate is a stimulant designed to increase the activity of the central nervous system.

A placebo is not a drug. It looks like the study drug but is not designed to treat any symptom, disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

The exercise in this study is designed to help improve your physical fitness and energy levels.

Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression, pain, and/or sleep disorders.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: American Cancer Society, Inc.
• Treatments: Androgens; Methylphenidate

Criteria

Inclusion Criteria:

1. Have a diagnosis of prostate cancer and are scheduled to receive radiotherapy with androgen deprivation therapy

2. Rate fatigue at least 1 or higher on a scale of 0-10.

3. Describe fatigue as being present every day for most of day for a minimum of 2 weeks.

4. Have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale (MDAS) score of

5. Be aged 18 years or older.

6. Be willing to engage in follow-up telephone calls with a research nurse/coordinator.

7. Be willing to participate in the exercise and in Cognitive Behavioral Therapy (CBT).

8. Have telephone access to be contacted by the research nurse/coordinator.

9. Have a hemoglobin level of >/=10 g/dL within 2 weeks of enrollment.

10. Be able to understand the description of the study and give written informed consent.

11. Have a Zubrod performance status of 0 to 2.

Exclusion Criteria:

1. 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.

2. Be currently taking MP or have taken it within the previous 10 days.

3. Are regularly engaged in moderate- or vigorous-intensity exercise for at least 150 minutes per week.

4. Regularly used cognitive behavioral therapy in the last 6 weeks.

5. Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.

6. Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine.

7. Have glaucoma.

8. Have with history of severe cardiac disease (New York Heart Association functional class III or IV).

9. Have tachycardia and/or uncontrolled hypertension

10. Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).

11. History of uncontrolled hypothyroidism as evidenced by thyroid test (TSH) within the last month, hypercalcemia or hyperglycemia (within the last 15 days).

12. Unable to speak and understand English

13. Any medical or psychological condition or any reason that, according to the investigator's judgment, makes the patient unsuitable for participation in the study.