NCT03772834

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

A Combination Therapy to Treat Cancer-Related Fatigue - NCI R01

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine if the combination of exercise (EX) plus methylphenidate (MP) is superior to exercise plus placebo in the treatment of cancer-related fatigue (CRF) in patients with prostate cancer scheduled to receive radiotherapy with androgen deprivation therapy for 12 weeks. SECONDARY OBJECTIVE: I. To determine the effects of combined exercise plus methylphenidate on quality-of-life, mood, physical, and cognitive measures. EXPLORATORY OBJECTIVES: I. To identify potential synergistic effects of exercise and methylphenidate in improvement of CRF. II. To explore changes in brain activity by electroencephalography (EEG) in responders (with 4 point or greater change in Functional Assessment of Chronic Illness Therapy-Fatigue \[FACIT-F\] scores) versus (vs) non-responders to the intervention. OUTLINE: Patients are randomized to 1 of 4 groups. GROUP I: Patients receive methylphenidate orally (PO) twice daily (BID) and undergo exercise program consisting of resistance training twice weekly (BIW) and walking 15- 40 minutes a day 4 days a week for 12 weeks. GROUP II: 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. GROUP III: Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks. GROUP IV: Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks. After completion of study treatment, patients are followed up at 3 months.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Intervention	Undergo resistance training and walking
DRUG	Methylphenidate	Given PO
OTHER	Placebo	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Stretching	Undergo stretching

Timeline

• Start date: 2019-03-25
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2018-12-11
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study