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Fatigue-Busting combo: stimulant plus exercise tested in cancer patients

NCT ID NCT03525873

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase III trial tests whether the stimulant methylphenidate (Ritalin) combined with physical activity can reduce cancer-related fatigue in 212 patients with metastatic cancer who are receiving anti-PD1 immunotherapy. Participants are randomly assigned to receive either methylphenidate or a placebo, plus a physical activity program. The study measures changes in fatigue scores and daily activity levels over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methylphenidate (a central nervous system stimulant) and physical activity (aerobic and resistance exercises)
What this could lead to
If it works, this could point toward a drug-and-exercise combination to ease severe fatigue in people with advanced cancer on immunotherapy.
What could go wrong
This is a phase III trial, but fatigue is subjective and hard to measure. The drug may cause side effects like insomnia or anxiety, and the benefit may be small or not apply to all patients.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

212 people

The number who actually took part.

Started

Aug 2018

Expected to finish

Dec 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

Anyone

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: * Part 1: have a diagnosis of metastatic or recurrent cancer and previously received anti PD1 immunotherapy provided that they received therapy up to 1 month prior to enrollment * Part 1: be willing to engage in follow-up telephone calls with a research staff * Part 1: have telephone access so they can be contacted by the research staff * Part 1: hemoglobin level of \>= 8 g/dL within 2 weeks of enrollment \* Packed red blood cell (PRBC) transfusions will be allowed to patients with hemoglobin \< 8 g/dl * Part 1: be able to understand the description of the study and give written informed consent * Part 1: able to read, write and speak English * Part 2: have a diagnosis of metastatic or recurrent cancer and previously received anti PD1 immunotherapy provided that they received therapy up to 1 month prior to enrollment * Part 2: be willing to engage in follow-up telephone calls with a research staff * Part 2: have telephone access so they can be contacted by the research staff * Part 2: have a hemoglobin level of \>=8 g/dL within 2 weeks of enrollment \* PRBC transfusions will be allowed to patients with hemoglobin \< 8 g/dl * Part 2: be able to understand the description of the study and give written or verbal informed consent * Part 2: able to read, write and speak English * Part 2: presence of fatigue as defined FACIT-F subscale of =\< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue) * Part 2: not currently taking methylphenidate, or have taken it within the previous 10 days * Part 2: able to complete the baseline assessment forms * Part 2: able to understand the recommendations for participation in the study * Part 2: can be enrolled directly to part 2 independent of part 1 if on immunotherapy and having a FACIT-F fatigue =\< 34, and able to complete baseline assessment and bloodwork as detailed in Part 1 at baseline and day 14 +/-3 days. Treating Oncologist should agree for participation in the intervention trial Exclusion Criteria: * Part 1: patients will be excluded if (1) have clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of \>= 13 at baseline completed in person, by phone, or via video-conference * Part 2: Patients will be excluded if (1) have clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of \>= 13 at baseline completed in person, by phone, or via video-conference * Part 2: have a major contraindication to MP (e.g., allergy/hypersensitivity to study medications or their constituents), or conditions making adherence difficult as determined by the attending physician * Part 2: on monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine * Part 2: history of glaucoma * Part 2: history of have severe cardiac disease (New York Heart Association functional class III or IV) * Part 2: tachycardia and/or uncontrolled hypertension * Part 2: currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine) * Part 2: patients with Cut Down, Annoyed, Guilty and Eye Opener-Adapted to Include Drugs (CAGE-AID) \>= 2

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Conditions

The condition(s) this trial relates to.

cancer metastatic malignant neoplasm Neoplasm Metastasis Recurrence

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.