Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT03772834
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.
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.
Study:
NCT03772834
Study Brief:
Protocol Section:
NCT03772834