Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Head and Neck Neoplasms

Laryngeal Diseases

Psychotropic Drugs

All Drugs and Chemicals

Anti-Infective Agents

Central Nervous System Stimulants

Cardiotonic Agents

Bupropion

Minocycline

Modafinil

Antidepressive Agents

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Anti-Bacterial Agents

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.

Placebo

Armodafinil

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.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

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 + Minocycline

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

Total

<=18 years

Between 18 and 65 years

>=65 years

Age, Categorical

Female

Male

Gender

United States

Region of Enrollment

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

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

Dr. David Rosenthal Professor, Radiation Oncology Department

No analysis was completed. Study terminated with low enrollment.

Treatment Effects on 5 Selected Symptoms (Average MDASI-HNC Scores)

Overall Study

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

Curcumin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.

Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.

Initial Dose 100 mg two times a day (200 mg) for 10 weeks.

Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks.

Telephone Questionnaire

Zhongxing Liao, MD

The goal of this clinical research study is to compare armodafinil, bupropion, curcumin, and minocycline when given alone or in combination to learn which is better for controlling symptoms, such as the side effects of chemoradiation, when given to treat lung 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 4 study drugs that may help to reduce side effects. The study drugs will be tested alone and in combination with each other.

Armodafinil is designed to prevent excessive sleepiness.

Bupropion is an antidepressant with anti-inflammatory properties that may help reduce multiple symptoms.

Curcumin is the active ingredient in the spice, turmeric. It may interfere with the production of cytokines (which cause inflammation), which may reduce multiple symptoms.

Minocycline is an antibiotic. Minocycline has been shown to interrupt cytokine production, which may help to reduce multiple symptoms.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the roll of dice) to join 1 of 16 groups. You may be assigned to receive no study drugs, 1 study drug, or a combination of 2, 3, or all 4 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. However, all patients are under standard care by their treating doctors.

Neither you nor the study staff you will see in the clinic 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 you are receiving.

Study Drug Administration:

You will take the study drugs/placebos every day for 10 weeks. You will take either single or combined study drug(s) or placebos by mouth everyday as instructed by the study doctor.

You will be given pamphlets with more information about how to take the study drugs/placebos.

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

Completing the Symptom Questionnaire:

Throughout the study, you will be asked to complete the symptom questionnaire. You will be asked about symptoms from therapy you may be experiencing 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, study staff will ask you the questions and record your answers on paper or enter them into a computer. The symptom questionnaire will take up to 5 minutes to complete.

* 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.

Study Visits:

Before you begin chemoradiation:

* You will complete 4 questionnaires about pain and other symptoms, your mood, and your quality of life. Completing all 4 of the questionnaires will take about 15 minutes.
* You will have a blood coagulation test, called a 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.

After 4 weeks of chemoradiation:

* You will complete 1 questionnaire about your quality of life. This questionnaire will take about 2-3 minutes to complete.
* You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.

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

-You will complete 3 questionnaires about your symptoms, mood, and quality of life. These questionnaires will take about 10 minutes total to complete.

After about Week 7, the study staff will call you 2 times a 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 make take longer.

About Week 12 (at a routine clinical visit):

* You will complete 3 questionnaires about your symptoms, mood, and quality of life.
* If you were smoking at the beginning of the study, you will complete a questionnaire that asks if you stopped smoking any time during the study. This will take a few minutes.
* You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.
* You will be asked to complete another questionnaire that asks about your satisfaction with the study drug(s). This will take a few minutes.

Length of Study:

You will be on study for about 16 weeks. You will take the study drug(s) for 10 weeks and complete the symptom survey until 16 weeks. You will be taken off study 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. Curcumin is not FDA approved. At this time, curcumin is only being used in research. The different possible combinations of these drugs being used in this study is investigational.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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

Spots Global Cancer Trial Database for wellbutrin

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

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