Prostate CancerPhase 2NCT01410942
Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy
A Phase 2 study testing Methylphenidate, Counseling Sessions and Standardized Exercise Intervention Program in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Methylphenidate, Counseling Sessions and Standardized Exercise Intervention Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2012to 30 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read more
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.
Read the detailed description
If you are found eligible and agree to take part in the study:
- You will complete a baseline exercise assessment which will last about 30-45 minutes and include the following:
- A sit-to-stand test. You will sit in chair with your arms across your chest. Then you will be timed as you stand and sit down 5 times as quickly as possible.
- A hand-grip strength test. You will grip a device with each hand as hard as you can.
- A 6-minute walk test. You will be timed while you walk on a 100-foot loop. You will walk 50 feet and then turn and walk back to the beginning. You will do this at a walking speed that feels comfortable and for as many times as you can in 6 minutes.
- You will be given a belt (accelerometer) that you are required to wear for the first week of treatment. The accelerometer measures your physical activity.
Study Groups:
You will be randomly assigned (as in the roll of dice) to 1 of 8 study groups. You will have an equal chance of being assigned to any group. You will have a 50% chance of receiving the placebo.
The exercises and skills learned during counseling will be different for each study group. The study staff will talk to you about your assigned exercises and skills. You will be assigned to 1 of 2 types of exercise groups. One group will do resistance exercises and walking, and the other group will do stretching.
You be assigned to 1 of 2 types of counselling groups. One group will receive education on relaxation and symptoms. The other group will receive standard supportive counseling.
Neither you nor the medical study staff will know which group you are in. Only the study staff who will work with you for the exercise and counseling will know which group you are in. If needed for your safety, the medical staff will be able to find out which group you are in.
Study Drug/Placebo Administration:
You will take the methylphenidate/placebo capsules by mouth with water, 2 times each day. You must take both doses before 3 PM and wait at least 2 hours between doses.
Study Visits:
For all study visits/calls, you will be asked about any drugs you may be taking or any side effects that you may be having. At home during the study, you will continue practicing exercises from the exercise sessions and skills from the counseling sessions.
On Day 1, if not done at Screening:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs.
- You will complete 5 questionnaires, which should last about 30 minutes. The questionnaires ask about:
- Your emotional and physical well being
- Your level of fatigue
- Any anxiety and/or depression you may be having
- Any symptoms you may be having
On Day 8 (+/- 3 days):
- You will meet with a counselor. You will be asked to discuss your thoughts and feelings on different topics related to your well-being. The counseling session will last about 45 minutes.
- You will meet with the exercise trainer. The exercise trainer will teach you exercises and give you written instructions for how to do them at home. The exercise meeting will last about 30-45 minutes.
- You will be asked to complete a questionnaire that asks about any symptoms and/or side effects that you may be having. This should take about 10 minutes.
On Days 15 and 29 (+/- 3 days):
- You will exercise and then be asked how the exercises are going either in person or later over the phone. This should last about 30 minutes.
- You will have a counseling session with a counselor over the phone. This should last about 45 minutes.
- You will complete the 5 questionnaires.
On Days 22 and 36 (+/- 3 days) the exercise trainer and the counselor will call. These calls should last between 30-45 minutes.
On Day 43 (+/- 3 days) the exercise trainer and the counselor will call. These calls should last between 30-45 minutes.
-You will complete a questionnaire that asks about any symptoms and/or side effects you may be having. This should take about 10 minutes.
On Day 50 (+/- 3 days) the exercise trainer and the counselor will call if you have any uncompleted sessions. These calls should last between 30-45 minutes.
-You will be given an accelerometer that you are required to wear for the last week of treatment.
On Day 57 (+/- 10 days) you will return to the clinic:
- You will have a physical exam, including measurement of your vital signs.
- You will complete a sit-to-stand test.
- You will complete a hand-grip strength test.
- You will complete a 6-minute walk test.
- You will complete the 5 questionnaires.
Length of Study Participation:
You may continue taking the study drug/placebo for up to 57 days (+/- 10 days). You will no longer be able to take the study drug/placebo if the disease gets worse, if intolerable side effects occur, if you are unable to follow study directions, or if you cannot complete enough of the treatment combination as planned.
Your participation on the study will be over after you have completed the follow-up visit.
Follow-Up Visit:
About 3 months after your last dose of study drug/placebo, you will return to the clinic for a follow-up visit:
- You will be asked about any side effects you may have had.
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will complete a sit-to-stand test.
- You will complete hand-grip strength tests.
- You will complete a 6-minute walk test.
- You will be asked to complete the 5 questionnaires.
This is an investigational study. Methylphenidate tablets are FDA approved and commercially available for the treatment of attention deficit disorder (ADD). The methylphenidate capsules made from the methylphenidate tablets especially for this study are not approved by the FDA. The combination of methylphenidate, exercise, and counseling is considered investigational.
Up to 175 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Prostate Cancer
- Being tested
- Placebo, Methylphenidate, Counseling Sessions, Sham Exercise, Standardized Exercise Intervention Program
- Keywords
- Prostate Cancer, Multimodal Therapy, MMT, Fatigue, Cognitive Behavioral Therapy, CBT, Radiation therapy, Radiotherapy, RT, Functional Assessment of Chronic Illness Therapy - Fatigue, FACIT-F, Androgen deprivation therapy, Methylphenidate, Methylphenidate Hydrochloride, Ritalin, Concerta, Placebo, Sugar Pill
- Medical subject headings
- Prostatic Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Also called sugar pill
Capsules by mouth twice daily.
MethylphenidateDrug
Also called Methylphenidate Hydrochloride, Ritalin, Concerta
Starting dose 5 mg by mouth twice daily.
Counseling SessionsBehavioural
Also called Counseling
8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each.
Sham ExerciseOther
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.
Standardized Exercise Intervention ProgramOther
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 Behavioral Therapy (CBT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Sham Exercise | Placebo comparator | 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. Receives: Other: Placebo; Behavioral: Counseling Sessions; Other: Sham Exercise |
| Methylphenidate + Sham Exercise | Experimental | 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. Receives: Drug: Methylphenidate; Behavioral: Counseling Sessions; Other: Sham Exercise |
| Exercise + Placebo | Placebo comparator | 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. Receives: Other: Placebo; Behavioral: Counseling Sessions; Other: Standardized Exercise Intervention Program |
| Cognitive Therapy + Placebo | Placebo comparator | 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. Receives: Other: Placebo; Other: Sham Exercise; Other: Cognitive Behavioral Therapy (CBT) |
| Methylphenidate + Exercise | Experimental | 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. Receives: Drug: Methylphenidate; Behavioral: Counseling Sessions; Other: Standardized Exercise Intervention Program |
| Methylphenidate + Cognitive Therapy | Experimental | 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. Receives: Drug: Methylphenidate; Other: Sham Exercise; Other: Cognitive Behavioral Therapy (CBT) |
| Exercise + Cognitive Therapy + Placebo | Placebo comparator | 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 Receives: Other: Placebo; Other: Standardized Exercise Intervention Program; Other: Cognitive Behavioral Therapy (CBT) |
| Methylphenidate + Exercise + Cognitive Therapy | Experimental | 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. Receives: Drug: Methylphenidate; Other: Standardized Exercise Intervention Program; Other: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and on Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study start8 Feb 2012
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Sriram Yennurajalingam, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410942
- Sponsor's protocol ID
- 2011-0389
- Other IDs
- RSG-11-170-01-PCSM, NCI-2011-02764
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2011
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT01410942
- Acronym / sponsor ID
- 2011-0389
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Multimodal Therapy, MMT, Fatigue, Cognitive Behavioral Therapy, CBT, Radiation therapy, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 8 Feb 2012 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 5 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
If you are found eligible and agree to take part in the study:
- You will complete a baseline exercise assessment which will last about 30-45 minutes and include the following:
- A sit-to-stand test. You will sit in chair with your arms across your chest. Then you will be timed as you stand and sit down 5 times as quickly as possible.
- A hand-grip strength test. You will grip a device with each hand as hard as you can.
- A 6-minute walk test. You will be timed while you walk on a 100-foot loop. You will walk 50 feet and then turn and walk back to the beginning. You will do this at a walking speed that feels comfortable and for as many times as you can in 6 minutes.
- You will be given a belt (accelerometer) that you are required to wear for the first week of treatment. The accelerometer measures your physical activity.
Study Groups:
You will be randomly assigned (as in the roll of dice) to 1 of 8 study groups. You will have an equal chance of being assigned to any group. You will have a 50% chance of receiving the placebo.
The exercises and skills learned during counseling will be different for each study group. The study staff will talk to you about your assigned exercises and skills. You will be assigned to 1 of 2 types of exercise groups. One group will do resistance exercises and walking, and the other group will do stretching.
You be assigned to 1 of 2 types of counselling groups. One group will receive education on relaxation and symptoms. The other group will receive standard supportive counseling.
Neither you nor the medical study staff will know which group you are in. Only the study staff who will work with you for the exercise and counseling will know which group you are in. If needed for your safety, the medical staff will be able to find out which group you are in.
Study Drug/Placebo Administration:
You will take the methylphenidate/placebo capsules by mouth with water, 2 times each day. You must take both doses before 3 PM and wait at least 2 hours between doses.
Study Visits:
For all study visits/calls, you will be asked about any drugs you may be taking or any side effects that you may be having. At home during the study, you will continue practicing exercises from the exercise sessions and skills from the counseling sessions.
On Day 1, if not done at Screening:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs.
- You will complete 5 questionnaires, which should last about 30 minutes. The questionnaires ask about:
- Your emotional and physical well being
- Your level of fatigue
- Any anxiety and/or depression you may be having
- Any symptoms you may be having
On Day 8 (+/- 3 days):
- You will meet with a counselor. You will be asked to discuss your thoughts and feelings on different topics related to your well-being. The counseling session will last about 45 minutes.
- You will meet with the exercise trainer. The exercise trainer will teach you exercises and give you written instructions for how to do them at home. The exercise meeting will last about 30-45 minutes.
- You will be asked to complete a questionnaire that asks about any symptoms and/or side effects that you may be having. This should take about 10 minutes.
On Days 15 and 29 (+/- 3 days):
- You will exercise and then be asked how the exercises are going either in person or later over the phone. This should last about 30 minutes.
- You will have a counseling session with a counselor over the phone. This should last about 45 minutes.
- You will complete the 5 questionnaires.
On Days 22 and 36 (+/- 3 days) the exercise trainer and the counselor will call. These calls should last between 30-45 minutes.
On Day 43 (+/- 3 days) the exercise trainer and the counselor will call. These calls should last between 30-45 minutes.
-You will complete a questionnaire that asks about any symptoms and/or side effects you may be having. This should take about 10 minutes.
On Day 50 (+/- 3 days) the exercise trainer and the counselor will call if you have any uncompleted sessions. These calls should last between 30-45 minutes.
-You will be given an accelerometer that you are required to wear for the last week of treatment.
On Day 57 (+/- 10 days) you will return to the clinic:
- You will have a physical exam, including measurement of your vital signs.
- You will complete a sit-to-stand test.
- You will complete a hand-grip strength test.
- You will complete a 6-minute walk test.
- You will complete the 5 questionnaires.
Length of Study Participation:
You may continue taking the study drug/placebo for up to 57 days (+/- 10 days). You will no longer be able to take the study drug/placebo if the disease gets worse, if intolerable side effects occur, if you are unable to follow study directions, or if you cannot complete enough of the treatment combination as planned.
Your participation on the study will be over after you have completed the follow-up visit.
Follow-Up Visit:
About 3 months after your last dose of study drug/placebo, you will return to the clinic for a follow-up visit:
- You will be asked about any side effects you may have had.
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will complete a sit-to-stand test.
- You will complete hand-grip strength tests.
- You will complete a 6-minute walk test.
- You will be asked to complete the 5 questionnaires.
This is an investigational study. Methylphenidate tablets are FDA approved and commercially available for the treatment of attention deficit disorder (ADD). The methylphenidate capsules made from the methylphenidate tablets especially for this study are not approved by the FDA. The combination of methylphenidate, exercise, and counseling is considered investigational.
Up to 175 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo + Sham Exercise | Placebo comparator | Other: Placebo, Behavioral: Counseling Sessions, Other: Sham ExercisePlacebo 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 | Experimental | Drug: Methylphenidate, Behavioral: Counseling Sessions, Other: Sham ExerciseMethylphenidate 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 comparator | Other: Placebo, Behavioral: Counseling Sessions, Other: Standardized Exercise Intervention ProgramResistance 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 comparator | Other: Placebo, Other: Sham Exercise, Other: Cognitive Behavioral Therapy (CBT)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 | Experimental | Drug: Methylphenidate, Behavioral: Counseling Sessions, Other: Standardized Exercise Intervention ProgramMethylphenidate 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 | Experimental | Drug: Methylphenidate, Other: Sham Exercise, Other: Cognitive Behavioral Therapy (CBT)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. |
| Exercise + Cognitive Therapy + Placebo | Placebo comparator | Other: Placebo, Other: Standardized Exercise Intervention Program, Other: Cognitive Behavioral Therapy (CBT)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 + Exercise + Cognitive Therapy | Experimental | Drug: Methylphenidate, Other: Standardized Exercise Intervention Program, Other: Cognitive Behavioral Therapy (CBT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: sugar pillCapsules by mouth twice daily. | Other | Cognitive Therapy + Placebo, Exercise + Cognitive Therapy + Placebo, Exercise + Placebo, Placebo + Sham Exercise |
| MethylphenidateAlso: Methylphenidate Hydrochloride, Ritalin, ConcertaStarting dose 5 mg by mouth twice daily. | Drug | Methylphenidate + Cognitive Therapy, Methylphenidate + Exercise, Methylphenidate + Exercise + Cognitive Therapy, Methylphenidate + Sham Exercise |
| Counseling SessionsAlso: Counseling8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each. | Behavioural | Exercise + Placebo, Methylphenidate + Exercise, Methylphenidate + Sham Exercise, Placebo + Sham Exercise |
| Sham ExerciseParticipants 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. | Other | Cognitive Therapy + Placebo, Methylphenidate + Cognitive Therapy, Methylphenidate + Sham Exercise, Placebo + Sham Exercise |
| Standardized Exercise Intervention ProgramResistance 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. | Other | Exercise + Cognitive Therapy + Placebo, Exercise + Placebo, Methylphenidate + Exercise, Methylphenidate + Exercise + Cognitive Therapy |
| Cognitive Behavioral Therapy (CBT)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. | Other | Cognitive Therapy + Placebo, Exercise + Cognitive Therapy + Placebo, Methylphenidate + Cognitive Therapy, Methylphenidate + Exercise + Cognitive Therapy |
Primary outcome
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores
Time frame: Baseline and on Day 57
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sriram Yennurajalingam, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylphenidate, Counseling Sessions and Standardized Exercise Intervention Program in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores (time frame: Baseline and on Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.