Clinical trial · Interventional
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
A Combination Therapy to Treat Cancer-Related Fatigue - NCI R01
NCT03772834CI-TRIAL-00110175active not recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Intervention | Behavioral | — | UNRESOLVED |
| Methylphenidate | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Stretching | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group I (methylphenidate, resistance training, walking)
- description
- Patients receive methylphenidate PO BID and undergo exercise program consisting of resistance training BIW and walking 15- 40 minutes a day 4 days a week for 12 weeks.
- interventionNames
- Behavioral: Exercise Intervention
- Drug: Methylphenidate
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Group II (placebo, resistance training, stretching)
- description
- Patients receive a placebo PO BID and undergo exercise program consisting of resistance training BIW and walking 15-40 minutes a day for 4 days a week for 12 weeks.
- interventionNames
- Behavioral: Exercise Intervention
- Other: Placebo
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.