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

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ClinicalTrials.gov Identifier: NCT01746043

Recruitment Status : Completed

First Posted : December 10, 2012

Results First Posted : June 6, 2018

Last Update Posted : June 6, 2018

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 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.

Condition or disease	Intervention/treatment	Phase
Esophageal Cancer	Drug: Armodafinil Other: Placebo Drug: Minocycline Behavioral: Questionnaires	Phase 2

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Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	22 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Randomized Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer
Study Start Date :	February 2013
Actual Primary Completion Date :	January 2017
Actual Study Completion Date :	January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Minocycline Minocycline hydrochloride Armodafinil

Genetic and Rare Diseases Information Center resources: Esophageal Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Armodafinil + Placebo 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.	Drug: Armodafinil 150 mg by mouth once a day for 6 weeks. Other Name: Nuvigil Other: Placebo 1 capsule by mouth 2 times a day for 6 weeks. Other Name: Sugar pill Behavioral: Questionnaires 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. Other Name: Surveys
Experimental: Minocycline + Placebo 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.	Other: Placebo 1 capsule by mouth 2 times a day for 6 weeks. Other Name: Sugar pill Drug: Minocycline 100 mg by mouth 2 times a day for 6 weeks. Other Names: Dynacin Minocin Minocin PAC Myrac Solodyn Behavioral: Questionnaires 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. Other Name: Surveys
Experimental: Armodafinil + Minocycline 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.	Drug: Armodafinil 150 mg by mouth once a day for 6 weeks. Other Name: Nuvigil Drug: Minocycline 100 mg by mouth 2 times a day for 6 weeks. Other Names: Dynacin Minocin Minocin PAC Myrac Solodyn Behavioral: Questionnaires 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. Other Name: Surveys
Placebo Comparator: Placebos 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.	Other: Placebo 1 capsule by mouth 2 times a day for 6 weeks. Other Name: Sugar pill Behavioral: Questionnaires 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. Other Name: Surveys

Outcome Measures

Primary Outcome Measures :

Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks. [ Time Frame: Baseline, 6 weeks ]
Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Criteria

Inclusion Criteria:

Patients with a pathologically proven diagnosis of esophageal cancer
Patients > or = 18 years old
Patients who will receive chemotherapy and radiation therapy
Patients who speak English or Spanish
Patients must be willing and able to review, understand, and provide written consent before starting therapy
Patients must agree to discontinue St John's Wort herbal supplement use, and refrain from taking it while on protocol
Women of childbearing potential (women who are not postmenopausal for at least 1 year and are not surgically sterile) must have a negative urine pregnancy test
Sexually active males and females must agree to use effective birth control or to be abstinent for the duration of the study period
Women currently taking birth control pills or planning to start birth control pills must agree to an additional method of birth control (either abstinence or a barrier method) while on the study medication and for 1 additional month after study completion.

Exclusion Criteria:

Patients who are enrolled in other symptom management clinical trials
Patients currently taking methylphenidate and/or dextroamphetamine
Patients with a history of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, as documented in the patient medical records
Patients with pre-existing psychosis or bipolar disorder
Patients with pre-existing renal impairment: The screening cut off for serum creatinine >1.5 times the upper limit of normal, within the past 30 days, will be done by the oncologist to qualify for CXRT.
Patients with pre-existing hepatic impairment: The screening for total bilirubin >25.7 µmol/L (1.5 mg/dL) will be done by the oncologist to qualify for CXRT. The screening for > 2 times the upper limit of normal hepatotoxicity, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) will be done by the oncologist to qualify for CXRT.
Patients with pre-existing Tourette's syndrome
Patients with hypersensitivity to any tetracyclines
Patients with uncontrolled cardiac disease, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.
Patients taking medicines that are strong CYP3A4 inhibitors or inducers (including conivaptan, indinavir, nelfinavir, ritonavir, nefazodone, and phenetoin), or strong CYP2C19 inhibitors (including citalopram and clopidogrel).
Patients on vitamin K antagonist warfarin

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): NCT01746043

Locations

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United States, Texas
University of Texas 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:	Steven H. Lin, MD, PHD	M.D. Anderson Cancer Center

More Information

Additional Information:

University of Texas 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:	NCT01746043
Other Study ID Numbers:	2012-0117 NCI-2013-00584 ( Registry Identifier: NCI CTRP ) R01CA026582 ( U.S. NIH Grant/Contract )
First Posted:	December 10, 2012 Key Record Dates
Results First Posted:	June 6, 2018
Last Update Posted:	June 6, 2018
Last Verified:	May 2018

Keywords provided by M.D. Anderson Cancer Center:


Esophageal cancer Chemotherapy Radiation therapy XRT Chemoradiation CXRT Symptom Burden Armodafinil Nuvigil Minocycline	Dynacin Minocin Minocin PAC Myrac Solodyn Placebo Sugar pill Questionnaires Surveys

Additional relevant MeSH terms:

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Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Minocycline	Modafinil Anti-Bacterial Agents Anti-Infective Agents Central Nervous System Stimulants Physiological Effects of Drugs Wakefulness-Promoting Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action

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