200 Participants Needed

Methylphenidate + Exercise for Prostate Cancer

Sriram Yennu profile photo
Overseen BySriram Yennu
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.

What data supports the effectiveness of the treatment Exercise Program for Prostate Cancer?

Research shows that exercise can help reduce the side effects of prostate cancer treatments, improve muscle strength, and enhance quality of life for patients. Studies have found that supervised exercise programs can lead to better endurance, reduced depression, and improved overall health in men undergoing prostate cancer treatment.12345

Is the combination of exercise and methylphenidate safe for prostate cancer patients?

Exercise is generally safe for prostate cancer patients and can help manage treatment-related side effects like fatigue and muscle weakness. It is recommended to be done under supervision to maximize benefits and minimize risks. However, there is no specific safety data available for the combination of exercise and methylphenidate in this context.46789

How does the Methylphenidate + Exercise treatment for prostate cancer differ from other treatments?

This treatment is unique because it combines a medication, Methylphenidate, with an exercise program to potentially reduce the side effects of androgen-deprivation therapy (ADT) in prostate cancer patients. Exercise has been shown to improve quality of life and reduce fatigue, which are common issues with ADT, making this approach novel compared to standard treatments that do not typically include physical activity as a component.1681011

What is the purpose of this trial?

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.

Research Team

SY

Sriram Yennu, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.
See 7 more

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
See 5 more

Timeline

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

Treatment Details

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.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Group I (methylphenidate, resistance training, walking)Experimental Treatment4 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 Control4 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 Control4 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 Control4 Interventions
Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.

Find a Clinic Near You

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+

Findings from Research

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.
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]
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.
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]
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.
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]

References

Exercise-induced attenuation of treatment side-effects in patients with newly diagnosed prostate cancer beginning androgen-deprivation therapy: a randomised controlled trial. [2020]
Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. [2022]
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. [2022]
[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. [2019]
Mechanisms of Physical Activity Behavior Change for Prostate Cancer Survivors: A Cluster Randomized Controlled Trial. [2020]
Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. [2022]
Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. [2023]
Exercise overcome adverse effects among prostate cancer patients receiving androgen deprivation therapy: An update meta-analysis. [2021]
Exercise medicine for the management of androgen deprivation therapy-related side effects in prostate cancer. [2021]
Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. [2022]
Integrating diet and exercise into care of prostate cancer patients on androgen deprivation therapy. [2020]
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