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Can a stimulant plus exercise beat cancer fatigue?

NCT ID NCT03772834

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2019

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.