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.
Study sponsor and potential other locations can be found 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