Overview

Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer

Status:
Recruiting
Trial end date:
2023-11-30
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Methylphenidate
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
- 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).