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.
Additional locations may be listed on ClinicalTrials.gov for NCT03772834.
Locations matching your search criteria
United States
Texas
Houston
MD Anderson West HoustonStatus: Temporarily closed to accrual
Contact: Melissa Marlowe Joyner
Phone: 713-563-9600
M D Anderson Cancer CenterStatus: Temporarily closed to accrual
Contact: Sriram Yennu
Phone: 713-792-6085
PRIMARY OBJECTIVE:
I. To determine if the combination of exercise plus methylphenidate is superior to exercise plus placebo for 12 weeks in the treatment of cancer-related fatigue (CRF) in patients with prostate cancer receiving androgen deprivation therapy and/or radiation therapy.
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.
Trial PhasePhase II/III
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSriram Yennu