NCT03772834Active, not recruitingPhase 2/3
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
A Combination Therapy to Treat Cancer-Related Fatigue - NCI R01
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
This phase II/III trial studies how well methylphenidate and exercise work in reducing cancer-related fatigue in patients with prostate cancer. Methylphenidate is a type of central nervous system stimulant that can improve cognitive ability, mainly in memory and cognitive function. Exercise can improve mood and the physical aspects of cancer-related fatigue. Giving methylphenidate in combination with exercise may work better in reducing cancer-related fatigue in patients with prostate cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 7 Dec 2018
- Start date
- 25 Mar 2019
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT03772834
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 200
- From 25 Mar 2019 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Be currently taking MP, or have taken it within the previous 10 days
- Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine
- Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantone, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).
Other illness
- 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
- Have severe cardiac disease (New York Heart Association functional class III or IV)
- Have tachycardia and/or uncontrolled hypertension
Other
- 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
- Have glaucoma
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.