Esophageal CancerPhase 2NCT01746043
A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer
A Phase 2 study testing Armodafinil, Minocycline and Questionnaires in people with Esophageal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Armodafinil, Minocycline and Questionnaires
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jan 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Randomized Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer
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.
Read the 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.
- Conditions
- Esophageal Cancer
- Being tested
- Armodafinil, Placebo, Minocycline, Questionnaires
- Keywords
- Esophageal cancer, Chemotherapy, Radiation therapy, XRT, Chemoradiation, CXRT, Symptom Burden, Armodafinil, Nuvigil, Minocycline, Dynacin, Minocin, Minocin PAC, Myrac, Solodyn, Placebo, Sugar pill, Questionnaires, Surveys
- Medical subject headings
- Esophageal Neoplasms, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmodafinilDrug
Also called Nuvigil
150 mg by mouth once a day for 6 weeks.
PlaceboOther
Also called Sugar pill
1 capsule by mouth 2 times a day for 6 weeks.
MinocyclineDrug
Also called Dynacin, Minocin, Minocin PAC, Myrac
100 mg by mouth 2 times a day for 6 weeks.
QuestionnairesBehavioural
Also called Surveys
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.
| Study group | Role | What they receive |
|---|---|---|
| Armodafinil + Placebo | Experimental | 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. Receives: Drug: Armodafinil; Other: Placebo; Behavioral: Questionnaires |
| Minocycline + Placebo | Experimental | 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. Receives: Other: Placebo; Drug: Minocycline; Behavioral: Questionnaires |
| Armodafinil + Minocycline | Experimental | 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. Receives: Drug: Armodafinil; Drug: Minocycline; Behavioral: Questionnaires |
| Placebos | Placebo comparator | 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. Receives: Other: Placebo; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.
Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven H. Lin, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746043
- Sponsor's protocol ID
- 2012-0117
- Other IDs
- NCI-2013-00584, R01CA026582
- Status last verified
- May 2018
- First submitted
- 6 Dec 2012
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01746043
- Acronym / sponsor ID
- 2012-0117
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal cancer, Chemotherapy, Radiation therapy, XRT, Chemoradiation, CXRT, Symptom Burden, Armodafinil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Posted 6 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Armodafinil + Placebo | Experimental | Drug: Armodafinil, Other: Placebo, Behavioral: QuestionnairesArmodafinil 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 + Placebo | Experimental | Other: Placebo, Drug: Minocycline, Behavioral: QuestionnairesMinocycline 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 + Minocycline | Experimental | Drug: Armodafinil, Drug: Minocycline, Behavioral: QuestionnairesArmodafinil 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. |
| Placebos | Placebo comparator | Other: Placebo, Behavioral: QuestionnairesPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArmodafinilAlso: Nuvigil150 mg by mouth once a day for 6 weeks. | Drug | Armodafinil + Minocycline, Armodafinil + Placebo |
| PlaceboAlso: Sugar pill1 capsule by mouth 2 times a day for 6 weeks. | Other | Armodafinil + Placebo, Minocycline + Placebo, Placebos |
| MinocyclineAlso: Dynacin, Minocin, Minocin PAC, Myrac100 mg by mouth 2 times a day for 6 weeks. | Drug | Armodafinil + Minocycline, Minocycline + Placebo |
| QuestionnairesAlso: SurveysCompletion 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. | Behavioural | Armodafinil + Minocycline, Armodafinil + Placebo, Minocycline + Placebo, Placebos |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven H. Lin, MD, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Armodafinil, Minocycline and Questionnaires in people with Esophageal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.