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New combo therapy aims to beat cancer fatigue

NCT ID NCT01410942

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.