Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-14 @ 5:52 AM
Study NCT ID:
NCT03772834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-10
First Post:
2018-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Combination Therapy to Treat Cancer-Related Fatigue - NCI R01
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: