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 range
18 Years
Sex
MALE
See this in plain English?
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores
. 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.
. 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).