Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Fatigue

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Antineoplastic Agents

Central Nervous System Stimulants

Nilotinib

Dasatinib

Imatinib Mesylate

Modafinil

Patients randomized to nonintervention will take a placebo every morning for 2 weeks.

Three 50 mg tablets orally every morning for 2 weeks.

Placebo

Armodafinil

Carmen Escalante, MD

The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to control fatigue in patients with CML. The safety of this drug will also be studied.

The Study Drug:

Armodafinil is designed to help promote wakefulness in patients suffering from fatigue.

Study Groups:

If you are found to be eligible to take part in this study, you will take 3 tablets each day during Weeks 1, 2, 4, and 5. You will not take any tablets during Week 3.

You will be randomly assigned (as in the flip of a coin) to a study group. The tablets you receive will depend on which study group you are in. You will have an equal chance of being assigned to either group:

* If you are in Group 1, you will take armodafinil during Weeks 1 and 2 and a placebo during Weeks 4 and 5. A placebo is a tablet that looks like the study drug but has no active ingredients.
* If you are in Group 2, you will take a placebo during Weeks 1 and 2 and armodafinil during Weeks 4 and 5.

Neither you nor the study staff will know to which group you are assigned. However, if needed for your safety, the study staff will be able to find out what you are receiving at any time.

You will be given a fatigue diary and a drug diary. You will fill out the fatigue diary every day by answering 2 questions about fatigue. You will fill out the drug diary every day by writing when you take the study drug/placebo. You will return any unused drug/placebo at the end of Weeks 2 and 5.

At Week 5, you will be asked if you preferred the first period (Weeks 1 and 2 of the study) or the second period (Weeks 4 and 5 of the study). If your doctor thinks it is in your best interest and you are benefitting at this point, you will be able to continue taking the study drug and you will have additional study visits.

If you are one of the patients selected for the PK testing, the final results of the PK testing for your entire group will need to be completed before you can start the long term use of the study drug. If you take the study drug after Week 5, you will take 3 tablets every day for the rest of the time that you take the study drug.

Study Visits:

At the end of Weeks 1, 3, and 4:

* You will be asked about any symptoms that you may be having and about any other drugs that you may be taking.
* You will complete 2 questionnaires about fatigue and activity. It will take about 10 minutes to complete these questionnaires.
* Your blood pressure will be measured (Weeks 1 and 4 only).

At the end of Weeks 2 and 5:

* You will have a physical exam, including measurement of your weight and vital signs.
* You will complete the same questionnaires you completed at screening.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* If you were selected for PK testing during screening, you will also have PK blood samples drawn at the end of Week 2 and Week 5.
* You will complete the series of tests that check your memory, motor skills, and thinking that you completed at screening.

At Weeks 10, 15, 20, and 25:

* You will be asked about any symptoms that you may be having and about any other drugs that you may be taking.
* You will complete the 2 questionnaires about fatigue and activity.
* Your blood pressure will be measured.

If you are not scheduled to come to MD Anderson at Weeks 1, 3, 4, 10, 15, 20, and 25, the procedures to be performed at these times can be performed at home. You will be called and asked the questions described in these visits. You will take 2 separate blood pressure measurements 5 minutes apart for each day and report results to the research staff over the telephone. If you choose to take your blood pressure measurements at home, you will be provided with a home blood pressure monitor at screening and taught how to use it. The monitor will be returned to study staff at the end of the study.

Length of Study:

You may continue taking the study drug as part of this study for up to 24 weeks. If you are benefiting after 24 weeks, you may continue taking the study drug off study. If you are one of the patients selected for the PK testing, the final results of the PK testing for your entire group will need to be completed before you can start the long term use of the study drug. You will be taken off study at any time if you have intolerable side effects or if the study doctor thinks it is in your best interest.

End of Treatment:

About 6 months after the end of Week 5, the following tests and procedures will be performed:

* You will complete the same questionnaires you completed at screening.
* You will complete the series of tests that check your memory, motor skills, and thinking that you completed at screening.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* You will have a physical exam, including measurement of your weight and vital signs.

Follow-Up:

The study staff will call you about 30 days after your last dose of study drug and ask about any symptoms or complaints you may have had, as well as about any other drugs you may be taking. This call will last about 10 minutes.

This is an investigational study. Armodafinil is FDA approved and commercially available to help improve wakefulness in adults who experience excessive sleepiness. Its use in cancer-related fatigue is investigational.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients

Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia (CML) on Imatinib, Dasatinib, Nilotinib (or Any Other FDA Approved TKI for CML)

Efficacy defined by "fatigue worst" score from the Brief Fatigue Inventory (BFI) after each 2-week treatment period, using a 0 - 10 scale with 10 being WORST level of fatigue.

Cephalon

M.D. Anderson Cancer Center

Armodafinil Three 50 mg tablets orally every morning for 2 weeks.

Total

<=18 years

Between 18 and 65 years

>=65 years

Age, Categorical

Female

Male

Gender

United States

Region of Enrollment

Carmen Escalante, MD / Chair, General Internal Medicine

No analysis completed, study stopped due to slow accrual with only one participant.

Number of Participants With "Fatigue Worst" BFI Score

Overall Study

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Taken orally once a day in the morning. Dose will change depending upon level of fatigue

Eudocia Lee, MD

The purpose of this research study is to determine if armodafinil is safe and effective in treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy plus temodar. Armodafinil is a wakefulness-promoting agent that has been FDA approved for the treatment of excessive daytime sleepiness for a variety of disorders. Armodafinil may also help to reduce radiation-induced fatigue in brain tumor patients.

* Since no one knows for certain if armodafinil improves fatigue in brain tumor patients undergoing radiation therapy, participants will be randomized into one of two study groups. Half of the participants will receive armodafinil and the other half will receive pills with no medicine (placebo). Neither the participant or the study doctor will know what group they are in.
* Participants will be given a study medication-dosing calendar and will take either the study drug or placebo orally once a day for 8 weeks. The dose will be adjusted on days 8,22 or 43, depending upon the level of fatigue. Treatment will begin within 10 days from the radiation start date.
* Participants will be evaluated via documented clinician telephone call and self-administered questionnaires on days 1, 8, 22, 43 and 57.

A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas

A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas Undergoing Radiotherapy With or Without Standard Chemotherapy Treatment

The primary endpoint was the difference in the 42-day change (baseline vs. day 43) in Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F scale) between the 2 treatment groups (those patients randomized to receive armodafinil and those randomized to the placebo arm). FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials.5 It consists of the 27-item FACT-G (which assesses QOL based on physical, social/family, emotional, and functional well-being) and the 13-item FACIT-F fatigue subscale (which assesses the impact of fatigue on daily activities). Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). By scoring convention, after appropriate reversal scoring of 11 items, the FACIT-F fatigue subscale (FACIT-fatigue) score ranges from 0 to 52 (lower score indicating more fatigue). A score \< 30 indicates severe fatigue.

The effects of treatment on overall health-related quality of life quantified with the general Functional Assessment of Cancer Therapy survey (FACT-G) were measured at baseline, at day 22, at the end of radiation (day 43) and 2 weeks after completion of radiation (day 56). The FACT-G assesses quality of life based on physical, social/family, emotional, and functional well-being. Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). The total FACT-G score can range from 0-108, with higher scores indicating a better quality of life.

To assess the side effect profile of armodafinil in patients with malignant gliomas undergoing radiotherapy with or without standard chemotherapy treatment.

Dartmouth-Hitchcock Medical Center

University of California, San Diego

Beth Israel Deaconess Medical Center

Eudocia Quant Lee, MD

Center for Neuro-Oncology

Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.

Armodafinil: Taken orally once a day in the morning.

Placebo: Taken orally once a day in the morning.

Age, Continuous

Sex: Female, Male

Karnofsky Performance Status ranges from 0 (Dead) to 100 (Normal, no complaints, no evidence of disease) in increments of 10. This was measured at baseline, prior to any treatment on study.

Karnofsky Performance Status (KPS)

Grade 2

Grade 3

Grade 4

Grade not defined

Glioma is a broad category of brain and spinal cord. Gliomas can be grade I, II, III or IV. For the purposes of this study, Grade II, III, and IV were eligible for enrollment.

Glioma grade

Primary analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.

Change From Baseline in Fatigue at Day 43

FACIT-G (baseline vs day 22)

FACIT-G (baseline vs day 43)

FACIT-G (baseline vs day 56)

Analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.

Change From Baseline in Quality of Life at Days 22, 43 and 56

Abdominal pain

Confusion

Dehydration

Diarrhea

Glaucoma

Hyperkalemia

Hypokalemia

Hypomagnesemia

Ileus

Insomnia

Mood alteration (agitation)

Obstruction, cecum

Rash

Seizure

Speech impairment

Grade 3 - 4 events at least possibly related to study treatment.

Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment

Armodafinil: 150mg taken orally once a day in the morning.

Placebo: Taken orally once a day in the morning

Digestive System Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Anti-Infective Agents

Minocycline

Anti-Bacterial Agents

Armodafinil 150 mg by mouth once a day for 6 weeks. Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

Minocycline 100 mg by mouth 2 times a day for 6 weeks. Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

Armodafinil 150 mg by mouth once a day for 6 weeks. Minocycline 100 mg by mouth 2 times a day for 6 weeks.Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

1 capsule by mouth 2 times a day for 6 weeks.

100 mg by mouth 2 times a day for 6 weeks.

Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

Questionnaires

Steven H. Lin, MD, PHD

The goal of this clinical research study is to compare armodafinil and minocycline when given alone or in combination to learn which is better for controlling side effects of chemoradiation treatment for esophageal cancer (such as fatigue, pain, disturbed sleep, lack of appetite, and drowsiness).

Armodafinil is designed to prevent excessive sleepiness.

Minocycline is an antibiotic, which may help to reduce multiple symptoms.

In this study, you may receive a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Study Groups:

If you are eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to join 1 of 4 groups. You will have an equal chance of being in any group.

* Group 1 will take armodafinil and a placebo.
* Group 2 will take minocycline and a placebo.
* Group 3 will take armodafinil and minocycline.
* Group 4 will take 2 placebos.

Neither you nor the study staff you will see in the clinic will know if you are receiving the study drug(s) and/or the placebo(s). However, if needed for your safety, the study staff will be able to find out which study drug you are receiving.

If needed, you will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

Study Drug/Placebo Administration:

You will take the study drug/placebo 2 times a day for 6 weeks. You should take the capsules with a full glass of water. If you get an upset stomach, take them with food.

You will be given pamphlets with more information about how to take the study capsules.

You should bring your study capsules to every study visit.

Completing the Symptom Questionnaire:

Throughout the study, you will be asked to complete a questionnaire about your symptoms. This questionnaire will ask about symptoms from therapy you may be having and how they may be interfering with your daily activities. The study staff will either meet you during your regular clinic visit or call you at your home at a time that is convenient for you. In the clinic, you will complete the questionnaire by paper and pen, or by entering your answers into an electronic tablet computer. On the phone, a study staff member will ask you the questions and record your answers. You will complete the symptom questionnaire before you begin chemoradiation and then 1 time a week for the rest of the study. The symptom questionnaire will take up to 5 minutes to complete.

Study Visits:

Before you begin chemoradiation:

* You will complete questionnaires about pain and other symptoms, your mood, and your quality of life. Completing all 5 questionnaires will take about 15 minutes.
* If you can become pregnant and you did not have a pregnancy test during screening, you will have a urine pregnancy test. The study staff will give you the urine pregnancy test kit at your scheduled visit, and will review the results before you pick up the study capsules from the pharmacy.

About Week 3 or 4, you will be asked to complete a questionnaire that asks you about your satisfaction with the study capsules. This will take a few minutes.

During the last week of chemoradiation (about Week 5 or 6):

* You will complete 3 questionnaires about your symptoms, mood, and quality of life. These questionnaires will take about 10 minutes total to complete.
* You will also be asked to complete a questionnaire that asks about your satisfaction with the study capsules. This will take a few minutes.

After about Week 5 or 6, the study staff will call you 1 time a week to check on you until the study ends. This phone call should last only a few minutes. If you have had several side effects from chemoradiation, this phone call may take longer.

At your first routine clinical follow-up visit (about Week 10 to 14):

* You will complete the 3 questionnaires about your symptoms, mood, and quality of life.
* You will also be asked to complete another questionnaire that asks about your satisfaction with the study capsules.

Length of Study:

You will be on study for about 10-14 weeks. You will take the study drug(s) for 6 weeks and complete the symptom survey until the end of the study. You will be taken off study early if you have intolerable side effects.

This is an investigational study. Armodafinil is FDA approved and commercially available for the treatment of sleepiness. Minocycline is FDA approved and commercially available for the treatment of bacterial infections. The use of these drugs to help reduce chemoradiation symptoms is investigational.

Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.

A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer

A Randomized Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer

Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores

National Cancer Institute (NCI)

Armodafinil 150 mg once a day during the entire course of chemoXRT (6 weeks + 5 days) or a total of 6 weeks.

Minocycline 100 mg twice a day during the entire course of chemoXT ( 6 weeks + 5 days)

Armodafinil+Minocycline

Armodafinil 150mg once a day during the entire course of radiation (6 weeks + 5 days)

Armodafinil + Placebo

Minocycline 100mg twice a day during the entire course of radiation therapy (6 weeks + 5 days)

Minocycline + Placebo

Armodafinil (150 mg once a day for 6 weeks) + Minocycline (100 mg twice a day for 6 weeks).

Armodafinil + Minocycline

Ethnicity (NIH/OMB)

Lin,Steven H,M.D. Ph.D. / Radiation Oncology

Armodafinil (150mg once a day) + Minocycline (100mg once a day)

Placebos

Of the 21 randomized patients , 19 (90% were evaluable for the primary efficacy analysis).

Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.

Armodafinil 150mg once a day during the entire course of radiation (6 weeks + 5 days).

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Laryngeal Diseases

Psychotropic Drugs

Cardiotonic Agents

Bupropion

Antidepressive Agents

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

Armodafinil 150 mg by mouth once a day.

Minocycline 100 mg by mouth two times a day.

Armodafinil 150 mg by mouth once a day.

Bupropion 100 mg by mouth two times a day.

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

Armodafinil 150 mg by mouth once a day.

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

David I. Rosenthal, MD, MA, BA

The goal of this clinical research study is to compare armodafinil, bupropion, and minocycline when given alone or in combination. Researchers want to learn about the safety and level of effectiveness of these drugs in controlling symptoms, such as the side effects of chemoradiation, when given to patients with head and neck cancer.

The Study Drugs:

It is not known which study drug or combination of study drugs is better at reducing side effects patients may experience during chemoradiation therapy. For this reason, researchers have chosen 3 study drugs that may help to reduce side effects such as fatigue, pain, sleep disturbance, difficulty swallowing, and lack of appetite. The study drugs will be tested alone and in combination with each other.

* Armodafinil is designed to prevent excessive sleepiness.
* Bupropion and minocycline each may reduce inflammation, which may help to reduce other symptoms. Bupropion is a drug for depression. Minocycline is an antibiotic (a drug to treat infection).

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 8 groups. You may be assigned to receive no study drugs, 1 study drug, a combination of 2, or all 3 of the study drugs.

During this study, you may receive 1 or more placebos. A placebo looks like the study drug(s) but has no active ingredients. There is a chance that you will be in a group that does not receive any study drugs at all. The study drugs are being tested to learn if they can help control symptoms. All participants will be able to receive standard care for head and neck cancer outside of the study.

Neither you nor the study staff will know if you are receiving the study drugs and/or the placebo(s). However, if needed for your safety, the study staff will be able to find out which study drug(s) you are receiving.

Study Drug Administration:

You will take the study drugs/placebos 2 times every day for up to 10 weeks. You will take 1 or more study drug(s) or placebos by mouth each time, as instructed by the study doctor. If you have trouble swallowing the study drugs/placebos, they can be crushed just before taking them. You will be given information sheets on how to take the study drugs/placebos.

You will be given a daily diary to write down when you take the study drugs/placebos. You should bring your study drugs/placebos to the clinic to every study visit. You should also bring your diary to every study visit.

Symptom Questionnaire:

Throughout the study, you will be asked to fill out a symptom questionnaire. You will be asked about symptoms you may be experiencing and how they may be interfering with your daily activities. When you are in the clinic, the questionnaire can be completed by paper and pen with the study staff or by entering your answers into a computer. When you are away from the clinic, the questionnaire may be completed either through a phone call with the study staff or through a phone call from the interactive voice response (IVR) system. The symptom questionnaire will take up to 5 minutes each time. The study staff will give you the information you need to complete the questionnaire through the IVR system.

During Weeks 1-10, you will complete the symptom questionnaire 2 times a week. During Weeks 11-16, you will complete the symptom questionnaire 1 time a week.

If you would like, you can fill out a paper version of the questionnaire instead of using the phone system.

Study Visits:

Before you begin chemoradiation:

* You will fill out 6 questionnaires about pain and other symptoms, your mood, your tobacco and alcohol use, and the quality of your life. This should take about 15 minutes.
* You will have a blood coagulation test, called PT-INR, to make sure your blood clots normally.
* If you are a woman who is able to become pregnant, you will have a urine pregnancy test. The study staff will give you the pregnancy test kit at your scheduled visit, and will review and record the results of the test before your study prescriptions are filled by the pharmacy. This will also be done at about Weeks 4 and 7, at the first follow-up visit after radiation treatment, and 30 days after the study drugs are stopped.

At about Week 4 of chemoradiation:

* You will fill out 1 quality-of-life questionnaire. This should take about 2-3 minutes.
* You will be asked three questions about smoking after the start of chemoradiation therapy.
* You will have a blood coagulation test, called PT-INR, to make sure your blood clots normally.

During the last week of chemoradiation (about Week 7):

-You will fill out 3 questionnaires about your symptoms, mood, and quality of life. This should take about 10 minutes.

After about Week 7, the study staff will call you 2 times per week to check on you until Week 10. This phone call should last only a few minutes. If you have experienced several side effects from chemoradiation, this phone call may take longer.

At about Week 10 and at your first follow-up visit after your chemoradiation treatment:

* You will fill out 3 questionnaires about your symptoms, mood, and quality of life.
* You will fill out 2 questionnaires that ask about your smoking history and changes in your tobacco use during the study. This will take a few minutes.
* You will be asked to fill out another questionnaire that asks about your satisfaction with the study drug(s). For example, you will be asked if you thought the study drugs helped to control the symptoms, if you would recommend the study drugs to other patients, and if you had problems taking the study drugs. This will take a few minutes.
* In addition, at your first follow-up visit after your chemoradiation treatment, you will have a blood coagulation test, called PT INR, to make sure your blood clots normally.

Length of Study:

You will take the study drug(s)/placebo for up to 10 weeks, if the doctor thinks it is in your best interest. You will fill out the symptom questionnaires by phone until 16 weeks. You will no longer be able to take the study drug(s)/placebo if you experience intolerable side effects.

This is an investigational study. Armodafinil is FDA approved and commercially available for the treatment of excessive sleepiness. Bupropion is FDA approved and commercially available for the treatment of depression. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. The different possible combinations of these drugs being used in this study are investigational.

Up to 32 patients will take part in this study. All will be enrolled at MD Anderson.

Symptom Burden in Head and Neck Cancer

A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Head and Neck Cancer

Treatments ability to reduce values of 5 symptoms comprised of MD Anderson Symptom Inventory (MDASI)-Head and Neck Cancer (HNC) scores for fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite collected during the 10 weeks of chemoradiation treatment. symptoms that are caused by their disease or by their treatment. Symptom severity score is comprised of average of the five above MDASI core items (fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.

Placebo by mouth 2 times every day.

Placebo: 1 by mouth twice a day.

Armodafinil 150 mg by mouth once a day.

Armodafinil: 150 mg by mouth once a day.

Minocycline 100 mg by muth two times a day.

Minocycline: 100 mg by mouth twice a day.

Bupropion 100 mg by mouth two times a day.

Bupropion: 100 mg by mouth twice a day.

Armodafinil 150 mg by mouth once a day.

Minocycline 100 mg by mouth two times a day.

Armodafinil: 150 mg by mouth once a day.

Minocycline: 100 mg by mouth twice a day.

Armodafinil 150 mg by mouth once a day.

Bupropion 100 mg by mouth two times a day.

Armodafinil: 150 mg by mouth once a day.

Bupropion: 100 mg by mouth twice a day.

Armodafinil + Bupropion

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

Minocycline: 100 mg by mouth twice a day.

Bupropion: 100 mg by mouth twice a day.

Minocycline + Bupropion

Armodafinil 150 mg by mouth once a day.

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

Armodafinil: 150 mg by mouth once a day.

Minocycline: 100 mg by mouth twice a day.

Bupropion: 100 mg by mouth twice a day.

Armodafinil + Minocycline + Bupropion

Study halted due to low enrollment (one participant). No analysis completed.

Analysis was not possible due to early termination with only one participant accrued.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients	NCT01169753	Chronic Myeloid...	Placebo Armodafinil	18 Years -	M.D. Anderson Cancer Center
A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas	NCT00766467	Malignant Gliom...	Armodafinil Placebo	18 Years -	Dana-Farber Cancer Institute
A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer	NCT01746043	Esophageal Canc...	Armodafinil Placebo Minocycline Questionnaires	18 Years -	M.D. Anderson Cancer Center
A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer	NCT01746043	Esophageal Canc...	Armodafinil Placebo Minocycline Questionnaires	18 Years -	M.D. Anderson Cancer Center
Symptom Burden in Head and Neck Cancer	NCT01219673	Head And Neck C...	Placebo Armodafinil Minocycline Bupropion	18 Years - 65 Years	M.D. Anderson Cancer Center
Reducing Symptom Burden - Non Small Cell Lung Cancer (NSCLC)	NCT01048983	Non Small Cell ...	Armodafinil Bupropion Minocycline Curcumin Telephone Quest...	18 Years - 65 Years	M.D. Anderson Cancer Center
A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas	NCT00766467	Malignant Gliom...	Armodafinil Placebo	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for nuvigil

Every month we try and update this database with for nuvigil 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 nuvigil

Every month we try and update this database with for nuvigil 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 nuvigil 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.