Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiot… (NCT01410942) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy
United States175 participantsStarted 2012-02-08
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores