Multimodal Therapy for Fatigue in Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Sriram Yennurajalingam, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to learn about the effect of different combinations of exercise, supportive counseling, and methylphenidate/placebo for the treatment of fatigue in patients with prostate cancer. The safety of this treatment combination will also be studied. Methylphenidate is a stimulant designed to increase the activity of the central nervous system. A placebo is not a drug. It looks like the study drug but is not designed to treat any symptom, disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. The exercise in this study is designed to help improve your physical fitness and energy levels. Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression, pain, and/or sleep disorders.

Eligibility Criteria

This trial is for adults with prostate cancer experiencing daily fatigue, who are about to start radiotherapy with androgen deprivation therapy. They must not be heavily active or using certain therapies or medications that could interfere with the study, have a reasonable level of physical function (Zubrod status 0-2), and no severe cognitive issues or cardiac disease.

Inclusion Criteria

Be able to understand the description of the study and give written informed consent

I have felt extremely tired every day for at least two weeks.

I am 18 years old or older.

Exclusion Criteria

Unable to speak and understand English

I have glaucoma.

Have a major contraindication to MP (e.g., allergy/hypersensitivity to study medications or their constituents), exercise (e.g., cardiac disease), cognitive behavioral therapy (e.g., schizophrenia), or conditions making adherence difficult as determined by the attending physician

Participant Groups

The study tests how exercise, counseling, and methylphenidate (a stimulant) versus placebo affect fatigue in prostate cancer patients undergoing specific treatments. It explores different combinations of these interventions to see which might improve energy levels and overall well-being.

Group I: Methylphenidate + Sham Exercise Experimental Treatment 3 Interventions

Methylphenidate starting dose 5 mg by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.

Group II: Methylphenidate + Exercise + Cognitive Therapy Experimental Treatment 3 Interventions

Methylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.

Group III: Methylphenidate + Exercise Experimental Treatment 3 Interventions

Methylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.

Group IV: Methylphenidate + Cognitive Therapy Experimental Treatment 3 Interventions

Methylphenidate starting dose 5 mg by mouth twice daily. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.

Group V: Cognitive Therapy + Placebo Placebo Group 3 Interventions

Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily.

Group VI: Placebo + Sham Exercise Placebo Group 3 Interventions

Placebo capsules by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.

Group VII: Exercise + Placebo Placebo Group 3 Interventions

Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Placebo capsules by mouth twice daily.

Group VIII: Exercise + Cognitive Therapy + Placebo Placebo Group 3 Interventions

Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily

Methylphenidate is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Methylphenidate for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Narcolepsy

🇨🇦 Approved in Canada as Methylphenidate for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Narcolepsy

🇪🇺 Approved in European Union as Methylphenidate for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Narcolepsy

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Texas MD Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

American Cancer Society, Inc. Collaborator

References