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

StatusActive, Not Recruiting
PhasePhase 2
Started2012-02-08
View on ClinicalTrials.gov ↗
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.

Amendment history 2 changes detected by DataLookout

2026-09-04
critical
Primary completion pushed: 2026-09-30 → 2028-09-30
2026-09-04
minor
Completion pushed: 2026-09-30 → 2028-09-30
Trial Details
NCT Number NCT01410942
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: American Cancer Society, Inc.
Conditions Prostate Cancer
Enrollment 175 participants
Start Date 2012-02-08
Primary Completion 2028-09-30 (estimated)
Study Completion 2028-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-03