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

Prostate Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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 </=13 at baseline. 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Prostate Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:PlaceboCapsules by mouth twice daily.

Drug:MethylphenidateStarting dose 5 mg by mouth twice daily.

Behavioral:Counseling Sessions8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each.

Other:Sham ExerciseParticipants in placebo/sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.

Other:Standardized Exercise Intervention ProgramResistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.

Other:Cognitive Behavioral Therapy (CBT)8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Placebo + Sham ExercisePlacebo capsules by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.

Methylphenidate + Sham ExerciseMethylphenidate starting dose 5 mg by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.

Exercise + PlaceboResistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Placebo capsules by mouth twice daily.

Cognitive Therapy + PlaceboCognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily.

Methylphenidate + ExerciseMethylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.

Methylphenidate + Cognitive TherapyMethylphenidate starting dose 5 mg by mouth twice daily. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.

Exercise + Cognitive Therapy + PlaceboResistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily

Methylphenidate + Exercise + Cognitive TherapyMethylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.

Study Status

Active, not recruiting

Start Date: February 2012

Completed Date:

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Sriram Yennurajalingam, MD

Lead Sponsor: M.D. Anderson Cancer Center

Collaborator: American Cancer Society, Inc.

More information:https://clinicaltrials.gov/show/NCT01410942

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