Symptom Burden in Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT01219673

Recruitment Status : Terminated (Low accrual.)

First Posted : October 13, 2010

Results First Posted : February 10, 2015

Last Update Posted : February 10, 2015

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Head And Neck Cancer	Other: Placebo Drug: Armodafinil Drug: Minocycline Drug: Bupropion	Phase 1 Phase 2

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Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Head and Neck Cancer
Study Start Date :	March 2013
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head and Neck Cancer

Drug Information available for: Bupropion

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo Placebo by mouth 2 times every day.	Other: Placebo 1 by mouth twice a day.
Experimental: Armodafinil Armodafinil 150 mg by mouth once a day.	Drug: Armodafinil 150 mg by mouth once a day. Other Name: Nuvigil
Experimental: Minocycline Minocycline 100 mg by muth two times a day.	Drug: Minocycline 100 mg by mouth twice a day. Other Names: Dynacin Minocin Minocin PAC Myrac Solodyn
Experimental: Bupropion Bupropion 100 mg by mouth two times a day.	Drug: Bupropion 100 mg by mouth twice a day. Other Names: Wellbutrin Wellbutrin SR Zyban
Experimental: Armodafinil + Minocycline Armodafinil 150 mg by mouth once a day. Minocycline 100 mg by mouth two times a day.	Drug: Armodafinil 150 mg by mouth once a day. Other Name: Nuvigil Drug: Minocycline 100 mg by mouth twice a day. Other Names: Dynacin Minocin Minocin PAC Myrac Solodyn
Experimental: Armodafinil + Bupropion Armodafinil 150 mg by mouth once a day. Bupropion 100 mg by mouth two times a day.	Drug: Armodafinil 150 mg by mouth once a day. Other Name: Nuvigil Drug: Bupropion 100 mg by mouth twice a day. Other Names: Wellbutrin Wellbutrin SR Zyban
Experimental: Minocycline + Bupropion Minocycline 100 mg by muth two times a day. Bupropion 100 mg by mouth two times a day.	Drug: Minocycline 100 mg by mouth twice a day. Other Names: Dynacin Minocin Minocin PAC Myrac Solodyn Drug: Bupropion 100 mg by mouth twice a day. Other Names: Wellbutrin Wellbutrin SR Zyban
Experimental: Armodafinil + 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.	Drug: Armodafinil 150 mg by mouth once a day. Other Name: Nuvigil Drug: Minocycline 100 mg by mouth twice a day. Other Names: Dynacin Minocin Minocin PAC Myrac Solodyn Drug: Bupropion 100 mg by mouth twice a day. Other Names: Wellbutrin Wellbutrin SR Zyban

Outcome Measures

Primary Outcome Measures :

Treatment Effects on 5 Selected Symptoms (Average MDASI-HNC Scores) [ Time Frame: 10 weeks ]
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with a pathologically proven diagnosis of epithelial carcinoma of the oropharynx, nasopharynx, hypopharynx, larynx, or oral cavity being treated at MDACC.
Patients >/= 18 years old and </= 65 years old.
Patients with the above cancers scheduled to receive definitive concurrent chemoradiation over 6 - 7 weeks.
Patients who speak English (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol)
Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol.
Patients must be willing and able to review, understand, and provide written consent.
Women of childbearing potential (women who are not postmenopausal for at least one year and are not surgically sterile) must have negative urine pregnancy test..
Sexually active males and females must agree to use birth control or abstinence for the duration of the trial.

Exclusion Criteria:

Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions as determined by the treating physician
Patients taking CHANTIX (smoking cessation medication)
Patients who are enrolled in other symptom management trial or receiving active therapy as part of a treatment clinical trial.
Bile duct obstruction or cholelithiasis
History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction
Pre-existing psychosis or bipolar disorder. Patients with major depressive disorder or severe depression (a score of 13 or greater on the BDI Fast Screen (BDI-FS) will be excluded. If this is the case, we will notify their treating physician for appropriate management or referral.
Pre-existing renal impairment: The screening cut off for serum creatinine > the upper limit of normal, will be done by the oncologist to qualify for chemoradiation.
Pre-existing hepatic impairment: The screening for total bilirubin > 1.5 times the upper limit of normal will be done by the oncologist to qualify for chemoradiation. The screening for >2 times the upper limit of normal hepatotoxicity: Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT) will be done by the oncologist to qualify for chemoradiation.The screening results for Aspartate aminotransferase (AST) must be < 2 times the upper limit of normal if available in the medical records.
Pre-existing Tourette's syndrome
Seizure disorder
Anorexia/bulimia in past two months
Use of monoamine oxidase (MAO inhibitors) within 14 days
Patients undergoing abrupt discontinuation of ethanol or sedatives (including benzodiazepines)
Patients currently taking any of the study drugs
Hypersensitivity to any tetracyclines
Patients on anticoagulants (ie warfarin/heparin)
Patients with INR > 1.5.
Patients being treated with concurrent cetuximab chemotherapy with radiation therapy.
Patients currently receiving any tetracycline family antibiotic or within the previous past 14 days before chemoradiation.
Previous radiation therapy for a cancer in the head and neck region.
Patients with a history of cardiac disease, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.
Patients taking antifungals, antiretrovirals, and macrolides that are strong CYP3A4 strong inhibitors including indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, and nefazodone.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219673

Locations

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

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Principal Investigator:	David I. Rosenthal, MD, MA, BA	UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

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Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01219673
Other Study ID Numbers:	2009-0517 R01 026582-26 ( Other Grant/Funding Number: NCI )
First Posted:	October 13, 2010 Key Record Dates
Results First Posted:	February 10, 2015
Last Update Posted:	February 10, 2015
Last Verified:	January 2015

Keywords provided by M.D. Anderson Cancer Center:


Epithelial carcinoma Oropharynx Larynx Symptom-management Chemoradiation Placebo Armodafinil Nuvigil Bupropion	Wellbutrin Wellbutrin SR Zyban Minocycline Dynacin Minocin Minocin PAC Myrac Solodyn

Additional relevant MeSH terms:

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Head and Neck Neoplasms Neoplasms by Site Neoplasms Minocycline Modafinil Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action	Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Anti-Bacterial Agents Anti-Infective Agents Central Nervous System Stimulants Wakefulness-Promoting Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers

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