Multimodal Therapy for Fatigue in Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Anticoagulants, Anticonvulsants, Tricyclics, others

Disqualifiers: Cardiac disease, Schizophrenia, Glaucoma, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 57 days

175 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, such as monoamine oxidase inhibitors, tricyclic antidepressants, clonidine, anticoagulants, anticonvulsants, and some tricyclic drugs, to participate in this trial. If you are currently taking methylphenidate, you must stop at least 10 days before joining the study.

Is methylphenidate safe for treating fatigue in cancer patients?

Methylphenidate has been studied for treating fatigue in cancer patients and is generally safe, but it can cause side effects like headache, nausea, and dry mouth. In some studies, more people stopped taking it due to side effects compared to those taking a placebo. ^{1 2 3 4 5}

How does the drug methylphenidate differ from other treatments for fatigue in prostate cancer?

Methylphenidate is unique because it is a psychostimulant (a type of drug that increases activity in the brain) used to specifically target and reduce fatigue in cancer patients, including those with prostate cancer. Unlike other treatments, it can be patient-controlled, allowing individuals to manage their fatigue symptoms more directly. ^{3 4 6 7 8}

What data supports the effectiveness of the drug methylphenidate for reducing fatigue in prostate cancer patients?

Research shows that methylphenidate can help reduce fatigue in cancer patients, including those with prostate cancer, as it has been found to improve fatigue symptoms in several studies. For example, a study found that methylphenidate significantly improved fatigue symptoms in patients with chemotherapy-related fatigue. ^{1 3 4 6 9}

Who Is on the Research Team?

Sriram Yennurajalingam, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 willing to have follow-up calls with a research nurse.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline exercise assessment including sit-to-stand test, hand-grip strength test, and 6-minute walk test

1 day

1 visit (in-person)

Treatment

Participants receive methylphenidate/placebo, engage in exercise, and participate in cognitive therapy or supportive counseling

57 days

Multiple visits and calls (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including physical exams and performance tests

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy (CBT)
• Counseling Sessions
• Methylphenidate
• Placebo
• Sham Exercise
• Standardized Exercise Intervention Program

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Patient-controlled methylphenidate for the management of fatigue in patients with advanced cancer: a preliminary report. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Patient-controlled methylphenidate for cancer fatigue: a double-blind, randomized, placebo-controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Factors associated with response to methylphenidate in advanced cancer patients. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of dexmethylphenidate for the treatment of fatigue after cancer chemotherapy: a randomized clinical trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The use of methylphenidate to relieve fatigue. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

A phase II study of methylphenidate for the treatment of fatigue. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Effect of methylphenidate on fatigue in women with recurrent gynecologic cancer. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial. [2021]