Can a stimulant plus exercise beat cancer fatigue?
NCT ID NCT03772834
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether combining a stimulant drug (methylphenidate) with an exercise program can reduce severe fatigue in prostate cancer patients undergoing radiation and hormone therapy. About 200 participants will be assigned to drug plus exercise, drug alone, exercise alone, or a placebo. The goal is to improve energy and quality of life during treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2019
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Have a diagnosis of prostate cancer and be scheduled to receive radiotherapy with concurrent androgen deprivation therapy, and presence of fatigue with severity of 1/10, on a 0-10 scale for at least 2 weeks * 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 * Have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of \</=13 at baseline * Be aged 18 years or older * Be willing to engage in follow-up telephone calls with a research staff * Be willing to participate in the exercise programs * Have telephone access so they can be contacted by the research staff * Have a hemoglobin level of \>/= 10 g/dL within 2 weeks of enrollment * Be able to understand the description of the study and give written informed consent * Have a Zubrod performance status score of 0 to 2 * Seen at an outpatient clinic at MD Anderson Cancer Center, its Houston Area Locations (HALs) or Smith Radiation Oncology Clinic (HHS) Exclusion Criteria: * Have a major contraindication to MethylphenidateMP) (e.g., allergy/hypersensitivity to study medications or their constituents), exercise (e.g., cardiac disease), or conditions making adherence difficult as determined by the attending physician * Be currently taking MP, or have taken it within the previous 10 days * Be unable to complete the baseline assessment forms (e.g., due to language or sensory barriers) or to understand the recommendations for participation in the study * Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine * Have glaucoma * Have severe cardiac disease (New York Heart Association functional class III or IV) * Have tachycardia and/or uncontrolled hypertension * Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantone, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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