Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy
3 other identifiers
interventional
175
1 country
1
Brief Summary
The goal of this clinical research study is to learn about the effect of different combinations of exercise, supportive counseling, and methylphenidate/placebo for the treatment of fatigue in patients with prostate cancer. The safety of this treatment combination will also be studied. Methylphenidate is a stimulant designed to increase the activity of the central nervous system. A placebo is not a drug. It looks like the study drug but is not designed to treat any symptom, disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. The exercise in this study is designed to help improve your physical fitness and energy levels. Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression, pain, and/or sleep disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Feb 2012
Longer than P75 for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2011
CompletedFirst Posted
Study publicly available on registry
August 5, 2011
CompletedStudy Start
First participant enrolled
February 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
February 20, 2026
February 1, 2026
14.7 years
August 4, 2011
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores
Effects of various treatments\[exercise, Cognitive Behavioral Therapy (CBT), Methylphenidate\] and combinations of treatments in Multimodal Therapy (MMT) in reducing cancer-related fatigue in participants with prostate cancer receiving radiotherapy (RT), as measured by change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores taken at baseline and on Day 57.
Baseline and on Day 57
Study Arms (8)
Placebo + Sham Exercise
PLACEBO COMPARATORPlacebo 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.
Methylphenidate + Sham Exercise
EXPERIMENTALMethylphenidate 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.
Exercise + Placebo
PLACEBO COMPARATORResistance 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.
Cognitive Therapy + Placebo
PLACEBO COMPARATORCognitive 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 + Exercise
EXPERIMENTALMethylphenidate 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 + Cognitive Therapy
EXPERIMENTALMethylphenidate 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.
Exercise + Cognitive Therapy + Placebo
PLACEBO COMPARATORResistance 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 + Exercise + Cognitive Therapy
EXPERIMENTALMethylphenidate 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.
Interventions
Capsules by mouth twice daily.
Starting dose 5 mg by mouth twice daily.
8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each.
Participants in placebo/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.
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.
Eligibility Criteria
You may qualify if:
- Have a diagnosis of prostate cancer and are scheduled to receive radiotherapy with androgen deprivation therapy
- Rate fatigue at least 1 or higher on a scale of 0-10.
- Describe fatigue as being present every day for most of day for a minimum of 2 weeks.
- Have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale (MDAS) score of \</=13 at baseline.
- Be aged 18 years or older.
- Be willing to engage in follow-up telephone calls with a research nurse/coordinator.
- Be willing to participate in the exercise and in Cognitive Behavioral Therapy (CBT).
- Have telephone access to be contacted by the research nurse/coordinator.
- Have a hemoglobin level of \>/=10 g/dL within 2 weeks of enrollment.
- Be able to understand the description of the study and give written informed consent.
- Have a Zubrod performance status of 0 to 2.
You may not qualify if:
- 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.
- Be currently taking MP or have taken it within the previous 10 days.
- Are regularly engaged in moderate- or vigorous-intensity exercise for at least 150 minutes per week.
- Regularly used cognitive behavioral therapy in the last 6 weeks.
- Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.
- Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine.
- Have glaucoma.
- Have with history of severe cardiac disease (New York Heart Association functional class III or IV).
- Have tachycardia and/or uncontrolled hypertension
- Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).
- History of uncontrolled hypothyroidism as evidenced by thyroid test (TSH) within the last month, hypercalcemia or hyperglycemia (within the last 15 days).
- Unable to speak and understand English
- Any medical or psychological condition or any reason that, according to the investigator's judgment, makes the patient unsuitable for participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- American Cancer Society, Inc.collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sriram Yennurajalingam, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2011
First Posted
August 5, 2011
Study Start
February 8, 2012
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
February 20, 2026
Record last verified: 2026-02