drugset / Trial / NCT01410942

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

NCT01410942

Phase 2 Active not recruiting 175 enrolled M.D. Anderson Cancer Center American Cancer Society, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2012-02-08
Primary completion
2026-09-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 5 mg Oral

Indications