New combo therapy aims to beat cancer fatigue
NCT ID NCT01410942
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 4 times
Summary
This study looks at whether combining exercise, supportive counseling, and a stimulant drug (methylphenidate) can help reduce severe fatigue in prostate cancer patients who are receiving radiation and hormone therapy. About 175 adults with prostate cancer and daily fatigue will be assigned to different treatment combinations. The goal is to find the best way to improve energy and quality of life during cancer treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 175 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2012
- Expected to finish
-
Sep 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Have a diagnosis of prostate cancer and are scheduled to receive radiotherapy with androgen deprivation therapy 2. Rate fatigue at least 1 or higher on a scale of 0-10. 3. Describe fatigue as being present every day for most of day for a minimum of 2 weeks. 4. Have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale (MDAS) score of \</=13 at baseline. 5. Be aged 18 years or older. 6. Be willing to engage in follow-up telephone calls with a research nurse/coordinator. 7. Be willing to participate in the exercise and in Cognitive Behavioral Therapy (CBT). 8. Have telephone access to be contacted by the research nurse/coordinator. 9. Have a hemoglobin level of \>/=10 g/dL within 2 weeks of enrollment. 10. Be able to understand the description of the study and give written informed consent. 11. Have a Zubrod performance status of 0 to 2. Exclusion Criteria: 1. 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. 2. Be currently taking MP or have taken it within the previous 10 days. 3. Are regularly engaged in moderate- or vigorous-intensity exercise for at least 150 minutes per week. 4. Regularly used cognitive behavioral therapy in the last 6 weeks. 5. Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study. 6. Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine. 7. Have glaucoma. 8. Have with history of severe cardiac disease (New York Heart Association functional class III or IV). 9. Have tachycardia and/or uncontrolled hypertension 10. Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine). 11. History of uncontrolled hypothyroidism as evidenced by thyroid test (TSH) within the last month, hypercalcemia or hyperglycemia (within the last 15 days). 12. Unable to speak and understand English 13. Any medical or psychological condition or any reason that, according to the investigator's judgment, makes the patient unsuitable for participation in the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Prostate cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains