Methylphenidate + Exercise for Prostate Cancer

Overseen By Sriram Yennu

Age: 18+

Sex: Male

Trial Phase: Phase 2 & 3

Sponsor: M.D. Anderson Cancer Center

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

Disqualifiers: Glaucoma, Severe cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining the drug methylphenidate (commonly known as Ritalin) with exercise can reduce fatigue in people with prostate cancer. Methylphenidate typically improves focus and memory, while exercise can boost mood and reduce tiredness. The trial includes different groups: some will take methylphenidate and do resistance training, others will receive a placebo instead of the drug, and everyone will participate in some form of exercise. It is open to those with prostate cancer who are set to start radiotherapy with hormone therapy, feel tired often, and currently do not exercise much. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as methylphenidate, monoamine oxidase inhibitors, tricyclic antidepressants, clonidine, and some others. If you are currently taking any of these, you may need to stop before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that methylphenidate is usually safe and well-tolerated. Some studies suggest it might not be more effective than a placebo in reducing fatigue, yet it remains safe to use, with no major safety issues reported.

Regarding exercise, studies indicate that it is safe for men with prostate cancer. Exercise can enhance quality of life and fitness without causing serious side effects. Both treatments are generally safe and well-tolerated according to available research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining methylphenidate with exercise for prostate cancer because it introduces a fresh approach to managing fatigue and enhancing quality of life during treatment. Methylphenidate, commonly used for ADHD, may boost energy levels and improve mood, potentially helping patients better engage in physical activities. By incorporating resistance training and stretching, this approach goes beyond traditional treatments like hormone therapy or chemotherapy, aiming to holistically improve patient outcomes. This innovative combination could pave the way for less invasive, supportive therapies that enhance both physical and mental well-being during cancer treatment.

What evidence suggests that this trial's treatments could be effective for reducing cancer-related fatigue in prostate cancer patients?

Research has shown that methylphenidate, which participants in this trial may receive, can help reduce tiredness in men with prostate cancer, though it requires careful use due to possible side effects. Studies have found that it can significantly decrease feelings of exhaustion. Exercise, particularly a combination of strength and aerobic activities, is another treatment option in this trial and can improve overall quality of life and mental sharpness for prostate cancer patients. Exercise is also linked to reducing cancer severity and slowing its progression. This trial will test the use of methylphenidate alongside exercise to determine if it enhances these benefits, offering a promising way to manage cancer-related fatigue. ^{1 6 7 8 9}

Who Is on the Research Team?

Sriram Yennu, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult prostate cancer patients experiencing fatigue, who are about to start radiotherapy with androgen deprivation therapy. Participants should not be heavily involved in exercise, have a stable cognitive status, adequate hemoglobin levels, and must be able to consent and follow the study protocol.

Inclusion Criteria

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

I have prostate cancer, will get radiotherapy with hormone therapy, and have felt tired for at least 2 weeks.

I am willing to join the exercise programs.

Exclusion Criteria

I have a fast heart rate or high blood pressure that isn't controlled.

I have severe heart disease.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either methylphenidate or placebo and undergo an exercise or stretching program for 12 weeks

12 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Follow-up visit at 3 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention
• Methylphenidate

Trial Overview The trial is testing whether combining methylphenidate (a CNS stimulant) with an exercise program can reduce cancer-related fatigue more effectively than placebo in prostate cancer patients undergoing specific treatments.

How Is the Trial Designed?

Group I: Group I (methylphenidate, resistance training, walking) Experimental Treatment 4 Interventions

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.

Group II: Group IV (placebo, stretching) Active Control 4 Interventions

Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.

Group III: Group II (placebo, resistance training, stretching) Active Control 4 Interventions

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 IV: Group III (methylphenidate, stretching) Active Control 4 Interventions

Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A systematic review of 21 trials involving 1748 prostate cancer patients found that resistance exercise significantly improved body composition, functional capacity, and muscle strength, with a notable reduction in fat mass and an increase in lean mass.

The study suggests that lower volume resistance training at moderate to high intensity is just as effective as higher volume training, which may help make exercise more accessible and encourage adherence among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. Lopez, P., Taaffe, DR., Newton, RU., et al.[2023]

A supervised exercise program combining endurance and resistance training significantly improved various health markers in 27 prostate cancer patients undergoing androgen-deprivation therapy, including muscular endurance and cardiorespiratory fitness.

Participants also experienced improvements in quality of life, as evidenced by better performance in the six-minute walk test and reduced depression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. Caty, G., Salazar Gajardo, S., Butoescu, V., et al.[2019]

This study aims to evaluate the safety and efficacy of a 3-month modular multi-modal exercise program for 90 prostate cancer survivors with bone metastases, addressing concerns about muscle atrophy and functional impairments due to prior treatments.

The exercise program is designed to be safe for patients with bone metastases, potentially improving physical function and delaying skeletal complications, which could significantly enhance the quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. Galvão, DA., Taaffe, DR., Cormie, P., et al.[2022]

The ENGAGE study, involving 147 prostate cancer survivors, demonstrated that an exercise intervention significantly increased participants' task self-efficacy, meaning they felt more confident in their ability to engage in vigorous physical activity (VPA) after the program.

Task self-efficacy was found to partially mediate the positive effects of the exercise intervention on VPA, indicating that improving confidence in exercise capability is crucial for enhancing physical activity levels in prostate cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of Physical Activity Behavior Change for Prostate Cancer Survivors: A Cluster Randomized Controlled Trial. Craike, MJ., Gaskin, CJ., Mohebbi, M., et al.[2020]

A pilot randomized controlled trial involving 25 men with metastatic castrate-resistant prostate cancer (mCRPC) demonstrated that remotely monitored exercise training is feasible, safe, and acceptable, with 82% of participants completing the 12-week program.

Participants showed high adherence to the exercise regimen, completing 90% of aerobic and 96% of resistance training sessions, and reported high satisfaction with the program, indicating strong potential for future studies on exercise's impact on clinical outcomes in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and acceptability of a remotely monitored exercise pilot CHAMP: A Clinical trial of High-intensity Aerobic and resistance exercise for Metastatic castrate-resistant Prostate cancer. Kenfield, SA., Van Blarigan, EL., Panchal, N., et al.[2022]

Exercise interventions, including aerobic and resistance training, are safe for men undergoing androgen-deprivation therapy for prostate cancer and can improve muscular strength, cardiorespiratory fitness, functional performance, and reduce fatigue.

While exercise shows promise in mitigating some adverse effects of treatment, the effects on bone health, cardiometabolic risk, and quality of life remain unclear, indicating a need for further high-quality research to establish specific exercise guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. Gardner, JR., Livingston, PM., Fraser, SF.[2022]

Androgen deprivation therapy (ADT) for prostate cancer can lead to significant adverse effects, including sexual dysfunction, osteoporosis, and increased risk of cardiovascular disease, necessitating new management strategies.

Exercise and dietary interventions may effectively mitigate these ADT-associated side effects, offering accessible and low-cost options, although individualized assessments are essential due to the lack of large-scale trials specifically for prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating diet and exercise into care of prostate cancer patients on androgen deprivation therapy. Moyad, MA., Newton, RU., Tunn, UW., et al.[2020]

This phase III randomized controlled trial involves 866 participants with metastatic castrate-resistant prostate cancer (mCRPC) to assess whether supervised high-intensity aerobic and resistance exercise can improve overall survival compared to self-directed exercise.

The study will also explore the relationship between exercise and various health factors, such as immune function and metabolic biomarkers, which may help understand how exercise impacts survival outcomes in mCRPC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. Newton, RU., Kenfield, SA., Hart, NH., et al.[2022]

Exercise significantly improves muscle strength, exercise tolerance, and helps manage body fat and sexual function in prostate cancer patients undergoing androgen deprivation therapy (ADT), based on a meta-analysis of 15 studies with 1135 participants.

No significant differences were found between aerobic and resistance exercise in alleviating ADT-related obesity, fatigue, or exercise tolerance, and exercise duration was linked to reduced fatigue levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise overcome adverse effects among prostate cancer patients receiving androgen deprivation therapy: An update meta-analysis. Yunfeng, G., Weiyang, H., Xueyang, H., et al.[2021]

Exercise significantly benefits men undergoing androgen deprivation therapy (ADT) for prostate cancer by improving various health aspects such as aerobic fitness, muscular strength, quality of life, and mental wellbeing, without negatively affecting the efficacy of ADT.

The review supports that exercise can be safely integrated into routine prostate cancer care, with recommendations for moderate-to-high intensity aerobic and resistance training supervised by qualified professionals to maximize therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise medicine for the management of androgen deprivation therapy-related side effects in prostate cancer. Cormie, P., Zopf, EM.[2021]

A 3-month supervised exercise program for 50 prostate cancer patients starting androgen-deprivation therapy (ADT) significantly improved their quality of life and reduced cardiovascular risk, even after exercise was withdrawn.

While exercise training prevented declines in cardiopulmonary fitness and fatigue during the program, these benefits were not maintained after the program ended, highlighting the importance of ongoing physical activity for sustained health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-induced attenuation of treatment side-effects in patients with newly diagnosed prostate cancer beginning androgen-deprivation therapy: a randomised controlled trial. Ndjavera, W., Orange, ST., O'Doherty, AF., et al.[2020]

Citations

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Comparing aerobic and resistance exercise emphasis ... This study aimed to determine the feasibility of an aerobic-emphasised (AE) versus a resistance-emphasised (RE) exercise intervention in men with prostate ...

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The Effect of Resistance and/or Aerobic Training on Quality of ... The results show that combining strength and aerobic exercise significantly improves quality of life, especially in general health, mental clarity, and sexual ...

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Effects of exercise training on prostate cancer Exercise has emerged as a promising strategy, with evidence suggesting its efficacy in reducing cancer severity, inhibiting tumor progression and metastasis.

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Exercise and Psychosexual Education to Improve Sexual ... In this randomized clinical trial including 112 patients with prostate cancer, exercise improved erectile function compared with usual care.

5. nature.com nature.com/articles/s41391-021-00406-4

Exercise medicine in men with prostate cancer Exercise intervention studies in men with prostate cancer have shown well documented improvements in objective and self-reported outcomes ...

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A comparison of aerobic- and resistance-emphasised ... Most exercise studies in men with prostate cancer have utilised single exercise groups that combine resistance and aerobic exercise [[21], [22], ...

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The Effect of Resistance and/or Aerobic Training on Quality ... Conclusions: RT and combined RT/AT significantly improve QoL, fitness, and body composition in PC patients, with no detectable effect on PSA or lipid levels.

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0263918

The effects of exercise on body composition of prostate cancer ... This review suggested that exercise ameliorated the ADT-related side effects on body composition among prostate cancer patients, with longer and ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10854832/

The Impact of Physical Activity on the Outcomes ... The present review explores the impact of physical activity (PA) on patients with prostate cancer (PCa) managed through active surveillance ...