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Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy
Sponsor: M.D. Anderson Cancer Center
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.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
175
Start Date
2012-02-08
Completion Date
2026-09-30
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Interventions
Placebo
Capsules by mouth twice daily.
Methylphenidate
Starting dose 5 mg by mouth twice daily.
Counseling Sessions
8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each.
Sham Exercise
Participants 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.
Standardized Exercise Intervention Program
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 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.
Locations (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, United States