Neoplasms

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Digestive System Diseases

Breast Neoplasms

Fatigue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Central Nervous System Stimulants

All Drugs and Chemicals

Cardiotonic Agents

Methylphenidate

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Methylphenidate 18 mg oral daily for 2 weeks then Placebo oral daily for 2 weeks

Placebo oral daily for 2 weeks then Methylphenidate 18 mg oral daily for 2 weeks

Placebo

Carmen Escalante, MD

The goal of this clinical research study is to see if the drug OROS Methylphenidate HCl (Concerta) can help to control fatigue in patients with breast, gastrointestinal, lymphoma, myeloma or lung cancer who are going through chemotherapy or hormonal treatment or have completed chemotherapy or hormonal treatment in the last 12 months. The safety of this drug will also be studied. Another goal of the study is to see how certain cytokines change while patients undergo chemotherapy or hormonal treatment.

OROS Methylphenidate HCl is a mild central nervous system stimulant. Cytokines are a type of protein found in blood. Medical researchers here at M. D. Anderson are working to see if they are related to, or can tell us something about, fatigue and its symptoms.

This study will be divided into two, 14-day periods. During one of the 14-day periods, you will be given the study drug. During the other period, you will be given a placebo. A placebo is a sugar tablet that looks just like the study drug tablet.

You will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. In one group you will receive the study drug first and the placebo second. In the other group you receive the placebo first and the study drug second. The chance of being in either treatment group is about equal. Neither you nor the research staff will know which treatment order you are assigned to.

Before treatment starts, you will fill out questionnaires about your level of fatigue, distress, symptoms, and general health. It should take about 5 minutes to complete the questionnaires. You will have a medical history, physical exam (with pulse, temperature, blood pressure), and blood work done. At the start of the study a test of the heart called an EKG will be done. At the start of the study, and after you finish the study, you will complete additional questionnaires that measure mood, fatigue, sleep, and appetite. It should take about 15 minutes to complete the questionnaires. You will also complete a series of tests for memory, visual-motor, and thinking functions. These tests should take about 30 minutes to complete. (This evaluation may take place on or before Day 1 of the study.)

On Day 1, a set of study medications and a diary will be given to you. For the first fourteen days of the study, you will take the assigned study medication (either drug or placebo). Everyday you will fill out the diary, noting the time you took the study medication and answering two questions about your fatigue.

On Day 7, study personnel will see you in the clinic or Ambulatory Treatment Center. The delegated research personnel will take your blood pressure and pulse and ask you about any symptoms or complaints you may have had or any medications you may have taken.

On Day 14, study personnel will see you in the clinic or the Ambulatory Treatment Center where blood pressure and pulse will be measured. Unused study medication will be returned and your diary will be reviewed with the delegated research personnel. You will complete questionnaires asking about fatigue, sleep, depression, and symptoms. It should take about 15 minutes to complete them. You will also complete a series of tests for memory, visual-motor, and thinking functions. The tests should take about 30 minutes to complete. A blood draw will be done to look for changes in hemoglobin and for cytokine analysis.

A new set of study medications and a diary will be given to you. You will follow the same instructions as the first time period. You will take the assigned study medication every morning and fill out the diary, noting the time you took the study medication and answering two questions about your fatigue.

On Day 21, the same activities as Day 7 will occur.

If you are not scheduled to come to M. D. Anderson on Day 7 and Day 21, you will take 2 separate blood pressure measurements 5 minutes apart for each day and report results within 24 hours to the research staff. If you choose to take your blood pressure measurements at home, you need to bring your monitor at study enrollment to have measurements double-checked by research staff.

On Day 28, the study will end. The same activities as Day 14 will occur. In addition, you will have a physical exam.

You will be asked if you prefer the first (first 2 weeks of study) or second (second 2 weeks of study) treatment phase. If you want to continue taking the OROS Methylphenidate you will be allowed to do so off-study as long as there are no medical reasons not to.

This is an investigational study. The study drug has been approved for attention-deficit hyperactivity disorder but is investigational as a treatment for cancer related fatigue. The study medication and physical exams will cost you nothing. You will be reimbursed with a fixed amount of money for each scheduled study visit. The payment will be in the form of a gift card for parking expenses and a gift card for gas expenses. The study doctor or study staff can tell you more about when you will be able to receive reimbursement. A total of 50 patients will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson.

Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients

A Randomized, Double Blind, Two Period, Placebo-Controlled Crossover Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients

The primary endpoint is the "fatigue worst" score (range: 0 - 10) on the Brief Fatigue Inventory (BFI) at the end of two-week treatment (either Methylphenidate or placebo). "Worst fatigue" is defined as participants' rating of worst fatigue on a scale of 0 (no fatigue) to 10 (as bad as can imagine). Since each participant is expected to receive both 2-week of Methylphenidate or 2-week placebo at different times, they serve as their own control. The outcome is the difference in "fatigue worst" score between post-Methylphenidate measurement and post-Placebo measurement.

Ortho-McNeil Janssen Scientific Affairs, LLC

M.D. Anderson Cancer Center

18 mg Oral Daily for 2 Weeks

Placebo : Capsule By Mouth Daily x 2 Weeks

Methylphenidate : 18 mg By Mouth Daily x 2 Weeks

Methylphenidate Then Placebo

Placebo : Capsule By Mouth Daily x 2 Weeks

Methylphenidate : 18 mg By Mouth Daily x 2 Weeks

Placebo Then Methylphenidate

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Carmen Escalante, MD / Professor

As a crossover study, the potential carryover effect was examined first. The pooled data (the 2-week treatment for each intervention i.e. period 1 \& period 2) was used to assess the treatment effect (A versus B).

Methylphenidate 18 mg oral daily for 2 Weeks preceded or followed by Placebo oral daily for 2 weeks.

It is a crossover design and only the 33 patients who completed the study were included in the final data analysis.

Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement

Overall Study

Participants given a 7 day supply of 5 mg methylphenidate tablets (to take a maximum of 20 mg/day, for total of 28 tablets). Directions for use are to take one 5 mg tablet by mouth as needed every 2 hours for participant described significant fatigue (maximum of 4 tablets/day).

Evaluation of fatigue, ability to sleep, and general symptom questions at baseline visit, daily while on study drug, and on seventh day of treatment.

5 mg tablet by mouth as needed every 2 hours for participant described significant fatigue. Participants to take a maximum of 20 mg/day, for total of 28 tablets for 7 days.

Participants to have evaluation of their fatigue, ability to sleep, and will answer a set of general symptom questions at baseline visit, daily while on study drug, and on seventh day of treatment.

Fatigue Evaluations

Eduardo Bruera, MD

The goal of this clinical research study is to evaluate the effectiveness of ritalin (methylphenidate) taken on an as needed basis for the management of cancer related fatigue. The effects of methylphenidate on pain, mood, and sedation will be evaluated. Researchers will also evaluate the level of fatigue throughout the day and any possible causes of fatigue.

Fatigue is a major problem in cancer patients. Methylphenidate is a drug currently FDA approved for the treatment of attention deficit disorder and narcolepsy (sleep disorder). Methylphenidate has shown a benefit in improving thinking and decreasing drowsiness and pain in cancer patients taking opioids (pain killers). Methylphenidate has also shown a rapid response in treating depression.

Participants in this study will at first have an evaluation of their fatigue, ability to sleep, and they will answer a set of general symptom questions. It will take about 20 minutes to complete the evaluation. Participants will have a blood test called TSH (thyroid-stimulating hormone) performed to rule out the possibility of thyroid dysfunction as cause of fatigue.

The study will last for 7 days. Participants will be able to take up to four methylphenidate tablets a day on an as needed basis for fatigue. Participants will keep a daily diary where they will record their fatigue rating (0-10) before and 2 hours after taking methylphenidate. The research nurse will contact participants daily by phone (in person for in-patients) to make sure the daily diary is being filled out, to ask about side effects of treatment, and to ask participants to rate their fatigue at four times during the past day and about any possible causes of fatigue.

On the 7th day of treatment, participants will be evaluated in the palliative care clinic or by telephone. Evaluation of fatigue, ability to sleep, and general symptoms along with an evaluation of side effects and effectiveness of methylphenidate will be performed. The evaluation will take about 15 minutes to complete. If participants develop intolerable side effects while on study, the medication will be stopped and they will be removed from the study.

If participants find the drug beneficial and wish to continue taking it, they will be given a prescription for methylphenidate and can be followed as an outpatient in the palliative care clinic. Participants who choose to continue the medication will be evaluated at the end of 4 weeks for fatigue, ability to sleep, and general symptoms along with an evaluation of side effects and effectiveness by phone or in the clinic. The evaluation will take about 15 minutes to complete.

This is an investigational study. The use methylphenidate is investigational. A total of 36 patients will take part in this study. All will be enrolled at UTMDACC.

Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue - PRN Methylphenidate

Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue

Primary endpoint is fatigue as measured on a 10-point scale. An average 2-point reduction in fatigue from before to 2 hours after taking methylphenidate considered a clinical success.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Prostatic Neoplasms

Chronic Disease

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Chronic Graft Versus Host Disease

Androgens

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.

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.

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.

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 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.

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 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.

8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each.

Counseling Sessions

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.

Sham Exercise

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.

Standardized Exercise Intervention Program

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 Behavioral Therapy (CBT)

Sriram Yennurajalingam, MD

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.

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.

Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients	NCT00516269	Breast Cancer Fatigue Gastrointestina...	Methylphenidate Placebo	18 Years -	M.D. Anderson Cancer Center
Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue - PRN Methylphenidate	NCT02361125	Fatigue	Methylphenidate Fatigue Evaluat...	18 Years -	M.D. Anderson Cancer Center
Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue - PRN Methylphenidate	NCT02361125	Fatigue	Methylphenidate Fatigue Evaluat...	18 Years -	M.D. Anderson Cancer Center
Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients	NCT00516269	Breast Cancer Fatigue Gastrointestina...	Methylphenidate Placebo	18 Years -	M.D. Anderson Cancer Center
Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy	NCT01410942	Prostate Cancer	Placebo Methylphenidate Counseling Sess... Sham Exercise Standardized Ex... Cognitive Behav...	18 Years -	M.D. Anderson Cancer Center
Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients	NCT00516269	Breast Cancer Fatigue Gastrointestina...	Methylphenidate Placebo	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for concerta

Every month we try and update this database with for concerta cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for concerta

Every month we try and update this database with for concerta cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for concerta cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.