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Methylphenidate + Exercise for Prostate Cancer

Phase 2 & 3
Recruiting
Led By Sriram Yennu
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be aged 18 years or older
Have a Zubrod performance status score of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

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.

Who is the study for?
This trial is for adult prostate cancer patients experiencing fatigue, who are about to start radiotherapy with androgen deprivation therapy. Participants should not be heavily involved in exercise, have a stable cognitive status, adequate hemoglobin levels, and must be able to consent and follow the study protocol.Check my eligibility
What is being tested?
The trial is testing whether combining methylphenidate (a CNS stimulant) with an exercise program can reduce cancer-related fatigue more effectively than placebo in prostate cancer patients undergoing specific treatments.See study design
What are the potential side effects?
Methylphenidate may cause side effects like increased heart rate, high blood pressure, trouble sleeping, nervousness, and potential for addiction. Exercise might lead to muscle soreness or injury if not done properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Level of cancer-related fatigue in all groups
Secondary outcome measures
Change in quality of life, mood, physical and cognitive measures in all groups
Other outcome measures
Change in brain activity by electroencephalography (EEG) in responders versus non-responders as measured by the FACIT-F score
Synergistic effects of methylphenidate and exercise in all groups

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group I (methylphenidate, resistance training, walking)Experimental Treatment4 Interventions
Patients receive methylphenidate PO BID and undergo exercise program consisting of resistance training BIW and walking 15- 40 minutes a day 4 days a week for 12 weeks.
Group II: Group IV (placebo, stretching)Active Control4 Interventions
Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.
Group III: Group II (placebo, resistance training, stretching)Active Control4 Interventions
Patients receive a placebo PO BID and undergo exercise program consisting of resistance training BIW and walking 15-40 minutes a day for 4 days a week for 12 weeks.
Group IV: Group III (methylphenidate, stretching)Active Control4 Interventions
Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Intervention
2016
Completed Phase 4
~1330
Methylphenidate
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,099 Total Patients Enrolled
95 Trials studying Prostate Cancer
29,540 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,072 Total Patients Enrolled
560 Trials studying Prostate Cancer
506,895 Patients Enrolled for Prostate Cancer
Sriram YennuPrincipal InvestigatorM.D. Anderson Cancer Center
12 Previous Clinical Trials
1,357 Total Patients Enrolled

Media Library

Exercise Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03772834 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for patient recruitment in this research project?

"That is correct, the clinical trial detailed on clinicaltrials.gov is presently recruiting patients. This specific study was originally posted on March 25th, 2019 and has been updated as recently as September 21st, 2022. A total of 354 individuals are needed for this research project taking place at a single location."

Answered by AI

Are there any other precedents for this type of physical activity treatment?

"As of right now, there are 30 ongoing clinical trials studying the effects of Exercise Intervention. Out of those 30 active trials, 2 have reached Phase 3. Most of the research taking place for Exercise Intervention is based in Lexington, Kentucky; however, 43 different locations across the globe are running these sorts of studies."

Answered by AI

Are participants still being enrolled in this clinical trial?

"This information can be found on clinicaltrials.gov; the study is still recruiting patients. The original posting date was March 25th, 2019 with the most recent edit occurring on September 21st, 2022."

Answered by AI

Who else is applying?

What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am interested in giving back to the community and society in anyway I can.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
2019. "Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03772834.
All > Prostate Cancer Houston
~67 spots leftby Nov 2026
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