Study Summary
This trial is testing if a combination of methylphenidate (a type of central nervous system stimulant) and exercise can reduce cancer-related fatigue in patients with prostate cancer.
Eligible Conditions
- Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: Up to 12 weeks
Week 12
Change in brain activity by electroencephalography (EEG) in responders versus non-responders as measured by the FACIT-F score
Change in quality of life, mood, physical and cognitive measures in all groups
Up to 12 weeks
Level of cancer-related fatigue in all groups
Synergistic effects of methylphenidate and exercise in all groups
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
4 Treatment Groups
Group III (methylphenidate, stretching)
1 of 4
Group IV (placebo, stretching)
1 of 4
Group II (placebo, resistance training, stretching)
1 of 4
Group I (methylphenidate, resistance training, walking)
1 of 4
Active Control
Experimental Treatment
354 Total Participants · 4 Treatment Groups
Primary Treatment: Exercise Intervention · Has Placebo Group · Phase 2 & 3
Group I (methylphenidate, resistance training, walking)Experimental Group · 4 Interventions: Quality-of-Life Assessment, Exercise Intervention, Methylphenidate, Questionnaire Administration · Intervention Types: Other, Behavioral, Drug, Other
Group III (methylphenidate, stretching)ActiveComparator Group · 4 Interventions: Quality-of-Life Assessment, Methylphenidate, Questionnaire Administration, Stretching · Intervention Types: Other, Drug, Other, Other
Group IV (placebo, stretching)ActiveComparator Group · 4 Interventions: Placebo, Quality-of-Life Assessment, Questionnaire Administration, Stretching · Intervention Types: Other, Other, Other, Other
Group II (placebo, resistance training, stretching)ActiveComparator Group · 4 Interventions: Placebo, Quality-of-Life Assessment, Exercise Intervention, Questionnaire Administration · Intervention Types: Other, Other, Behavioral, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Intervention
2017
Completed Phase 4
~1810
Methylphenidate
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 weeks
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,025 Total Patients Enrolled
89 Trials studying Prostate Cancer
27,181 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,085 Previous Clinical Trials
41,141,157 Total Patients Enrolled
536 Trials studying Prostate Cancer
502,040 Patients Enrolled for Prostate Cancer
Sriram YennuPrincipal InvestigatorM.D. Anderson Cancer Center
12 Previous Clinical Trials
1,358 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Male Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a diagnosis of prostate cancer and are scheduled to receive radiotherapy with concurrent androgen deprivation therapy, and you have fatigue with severity of 1/10, on a 0-10 scale for at least 2 weeks.
You are able to understand the study and give written informed consent.
Patient not regularly engaging in moderate aerobic exercise for >90 minutes/week and/ or vigorous aerobic exercise for >30 minutes/week, and/ or strength training for >/= 1 day/week.
You have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of <13 at baseline.
You are willing to participate in follow-up telephone calls with a research staff.
You have telephone access.
You have a hemoglobin level of >/= 10 g/dL within 2 weeks of enrollment.
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Conditions
Cancer Related
Treatments