Status:
ACTIVE_NOT_RECRUITING
Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
American Cancer Society, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
If you are found eligible and agree to take part in the study: * You will complete a baseline exercise assessment which will last about 30-45 minutes and include the following: * A sit-to-stand test....
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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 (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.
Key Trial Info
Start Date :
February 8 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT01410942
Start Date
February 8 2012
End Date
September 30 2026
Last Update
August 15 2025
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030