Multimodal Therapy for Fatigue in Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how different combinations of exercise, supportive counseling, and the medication methylphenidate (a stimulant) can reduce fatigue in individuals with prostate cancer. Researchers seek to determine the effectiveness and safety of these treatments when administered together or separately. Individuals with prostate cancer who experience daily fatigue and are undergoing treatments such as radiation and hormone therapy may be suitable candidates. Participants should be willing to try new exercises and attend counseling sessions. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that methylphenidate, a type of stimulant, is generally safe for cancer patients, though it might not always outperform a placebo in reducing fatigue. Most patients tolerate it well, experiencing only mild side effects, with serious issues being rare.
Cognitive behavioral therapy, a form of counseling, has proven effective in reducing fatigue in cancer patients. It is safe and also provides mental health support.
Exercise is another treatment option. Studies indicate that exercise helps reduce fatigue and improves the quality of life for prostate cancer patients. It is safe and can increase energy levels.
This trial combines these treatments to evaluate their combined effectiveness. Each treatment has a good safety record, and the focus is on how well they reduce fatigue when used together.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for fatigue in prostate cancer because they combine multiple approaches to address this challenging symptom. Unlike the standard treatments, which often focus on a single method like medication or exercise, these treatments integrate cognitive therapy, exercise, and the stimulant methylphenidate. Methylphenidate is known for its potential to boost energy and focus, offering a new mechanism to tackle cancer-related fatigue. Moreover, the inclusion of cognitive therapy can help patients develop relaxation techniques and behavioral skills, while structured exercise routines aim to build stamina and physical resilience. This multimodal approach is hoped to provide a more comprehensive and effective relief from fatigue than current options.
What evidence suggests that this trial's treatments could be effective for fatigue in prostate cancer?
Research has shown that each component of this treatment plan can help reduce tiredness in prostate cancer patients. In this trial, participants may receive Methylphenidate, a medication that boosts energy and has been helpful in some cases for treating tiredness in men with prostate cancer, although other studies have shown mixed results. Some participants will engage in talking therapy, which involves speaking with a therapist to change thought patterns and has been effective in reducing cancer-related tiredness. Others will participate in exercise programs, which have also proven to improve tiredness and quality of life in cancer patients. Combining these treatments in various arms of the trial could offer several ways to address tiredness and enhance overall well-being.13678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete a baseline exercise assessment including sit-to-stand test, hand-grip strength test, and 6-minute walk test
Treatment
Participants receive methylphenidate/placebo, engage in exercise, and participate in cognitive therapy or supportive counseling
Follow-up
Participants are monitored for safety and effectiveness after treatment, including physical exams and performance tests
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?
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.
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.
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.
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.
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.
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.
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.
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:
- Attention Deficit Hyperactivity Disorder (ADHD)
- Narcolepsy
- Attention Deficit Hyperactivity Disorder (ADHD)
- Narcolepsy
- Attention Deficit Hyperactivity Disorder (ADHD)
- Narcolepsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
American Cancer Society, Inc.
Collaborator
Citations
Cognitive Behavioral Therapy for Cancer‐Related Fatigue
Cognitive behavioral therapy (CBT) has been shown effective in reducing CRF in both groups.
Fatigue in Prostate Cancer: A Roundtable Discussion and ...
Studies have shown that psychosocial methods, such as education and cognitive behavioural therapy, can be beneficial in reducing cancer-related ...
Original Article Cognitive behavioral therapy or graded ...
Conclusions. Among advanced cancer patients with severe fatigue during treatment, a CBT intervention was more effective than usual care for reducing fatigue.
A combined cognitive behavioral therapy for insomnia and ...
The intervention group showed improvements in insomnia, sleep quality, fatigue, anxiety, depression and health-related quality-of-life but ...
Fatigue Level Associated with Quality of Life for Prostate ...
This study evaluated the relationship between fatigue, QoL, and health outcomes among 6426 PCa patients. It found that 8.8% reported poor QoL, 20.9% had poor ...
Cognitive behavioral therapy or graded exercise ...
Among advanced cancer patients with severe fatigue during treatment, a CBT intervention was more effective than usual care for reducing fatigue.
Cognitive Behavioral Therapy for Cancer‐Related Fatigue ...
Cognitive behavioral therapy (CBT) has been shown effective in reducing CRF in both groups.
Multimodal therapy for the treatment of fatigue in patients ...
The project's objective is to explore the effects and safety of this MMT on CRF in prostate cancer patients scheduled to receive radiotherapy with androgen ...
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.