Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients with Prostate Cancer
Conditions
Prostate CarcinomaDrugs
MethylphenidateSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Sriram Yennu
- 713-792-6085
Principal Investigator
- Sriram Yennu
Eligibility Criteria
Inclusion Criteria:
* Have a diagnosis of prostate cancer and be scheduled to receive radiotherapy with concurrent androgen deprivation therapy, and presence of fatigue with severity of 1/10, on a 0-10 scale for at least 2 weeks
* Patient not regularly engaging in moderate aerobic exercise for >90 minutes/week and/or vigorous aerobic exercise for >30 minutes/week, and/ or strength training for >/= 1 day/week
* Have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of =13 at baseline
* Be aged 18 years or older
* Be willing to engage in follow-up telephone calls with a research staff
* Be willing to participate in the exercise programs
* Have telephone access so they can be contacted by the research staff
* Have a hemoglobin level of >/= 10 g/dL within 2 weeks of enrollment
* Be able to understand the description of the study and give written informed consent
* Have a Zubrod performance status score of 0 to 2
* Seen at an outpatient clinic at MD Anderson Cancer Center, its Houston Area Locations (HALs) or Smith Radiation Oncology Clinic (HHS)
Exclusion Criteria:
* Have a major contraindication to MethylphenidateMP) (e.g., allergy/hypersensitivity to study medications or their constituents), exercise (e.g., cardiac disease), or conditions making adherence difficult as determined by the attending physician
* Be currently taking MP, or have taken it within the previous 10 days
* Be unable to complete the baseline assessment forms (e.g., due to language or sensory barriers) or to understand the recommendations for participation in the study
* Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine
* Have glaucoma
* Have severe cardiac disease (New York Heart Association functional class III or IV)
* Have tachycardia and/or uncontrolled hypertension
* Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantone, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).
Study Plan
Group I (methylphenidate, resistance training, walking)
EXPERIMENTAL
Patients receive methylphenidate PO BID and undergo exercise program consisting of resistance training BIW and walking 15- 40 minutes a day 4 days a week for 12 weeks.
-
BEHAVIORAL:
Exercise InterventionDescription:
Undergo resistance training and walking -
DRUG:
MethylphenidateDescription:
Given PO -
OTHER:
Quality-of-Life AssessmentDescription:
Ancillary studies -
OTHER:
Questionnaire AdministrationDescription:
Ancillary studies
Group II (placebo, resistance training, stretching)
ACTIVE_COMPARATOR
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.
-
BEHAVIORAL:
Exercise InterventionDescription:
Undergo resistance training and walking -
OTHER:
PlaceboDescription:
Given PO -
OTHER:
Quality-of-Life AssessmentDescription:
Ancillary studies -
OTHER:
Questionnaire AdministrationDescription:
Ancillary studies
Group III (methylphenidate, stretching)
ACTIVE_COMPARATOR
Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.
-
DRUG:
MethylphenidateDescription:
Given PO -
OTHER:
Quality-of-Life AssessmentDescription:
Ancillary studies -
OTHER:
Questionnaire AdministrationDescription:
Ancillary studies -
OTHER:
StretchingDescription:
Undergo stretching
Group IV (placebo, stretching)
ACTIVE_COMPARATOR
Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.
-
OTHER:
PlaceboDescription:
Given PO -
OTHER:
Quality-of-Life AssessmentDescription:
Ancillary studies -
OTHER:
Questionnaire AdministrationDescription:
Ancillary studies -
OTHER:
StretchingDescription:
Undergo stretching
Outcome Measures
Primary Outcome Measures
Level of cancer-related fatigue in all groups
Secondary Outcome Measures
Change in quality of life, mood, physical and cognitive measures in all groups
Timeline
-
Last Updated
October 28, 2024 -
Start Date
December 11, 2018 -
Today
August 31, 2025 -
Completion Date ( Estimated )
November 30, 2026
Sponsors of this trial
-
Lead Sponsor
M.D. Anderson Cancer Center -
Collaborating Sponsors
National Cancer Institute (NCI)