Fatigue-Busting combo: stimulant plus exercise tested in cancer patients
NCT ID NCT03525873
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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212 people
The number who actually took part.
- Started
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Aug 2018
- Expected to finish
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Dec 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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Anyone
- 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.
Show the full entry requirements Hide 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.
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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