Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer

NCT03772834 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2018-0559NCI-2018-02527
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• Level of cancer-related fatigue in all groups

  Will measure cancer-related fatigue (CRF) using the area under the curve (AUC) of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale score. The intervention exposure will be operationalized as proportion of the total minutes of prescribed exercise intervention the study patient was actually able to participate, or the proportion of prescribed study medication the study patient was able to actually take.

  Up to 12 weeks

Secondary Outcomes (1)

• Change in quality of life, mood, physical and cognitive measures in all groups

  Baseline up to 12 weeks

Other Outcomes (2)

• Synergistic effects of methylphenidate and exercise in all groups

  Up to 12 weeks

• Change in brain activity by electroencephalography (EEG) in responders versus non-responders as measured by the FACIT-F score

  Baseline up to 12 weeks

Study Arms (4)

Group I (methylphenidate, resistance training, walking)

EXPERIMENTAL

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.

Behavioral: Exercise Intervention; Drug: Methylphenidate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group II (placebo, resistance training, stretching)

ACTIVE COMPARATOR

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.

Behavioral: Exercise Intervention; Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group III (methylphenidate, stretching)

ACTIVE COMPARATOR

Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.

Drug: Methylphenidate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Stretching

Group IV (placebo, stretching)

ACTIVE COMPARATOR

Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.

Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Stretching

Interventions

Exercise Intervention BEHAVIORAL

Undergo resistance training and walking

Group I (methylphenidate, resistance training, walking); Group II (placebo, resistance training, stretching)

Methylphenidate DRUG

Given PO

Also known as: Daytrana

Group I (methylphenidate, resistance training, walking); Group III (methylphenidate, stretching)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Group II (placebo, resistance training, stretching); Group IV (placebo, stretching)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (methylphenidate, resistance training, walking); Group II (placebo, resistance training, stretching); Group III (methylphenidate, stretching); Group IV (placebo, stretching)

Questionnaire Administration OTHER

Ancillary studies

Group I (methylphenidate, resistance training, walking); Group II (placebo, resistance training, stretching); Group III (methylphenidate, stretching); Group IV (placebo, stretching)

Stretching OTHER

Undergo stretching

Group III (methylphenidate, stretching); Group IV (placebo, stretching)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sriram Yennu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 11, 2018
• Study Start: March 25, 2019
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)