Lung CancerNCT01317550
A Study for Reducing Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer by Minocycline and Armodafinil
A study testing Armodafinil, Minocycline and Questionnaires in people with Lung 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 symptoms, such as the side effects of chemoradiation, when given to treat lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung 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
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Feb 2016
- Phase
- Interventional
- 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 NSCLC and consented to concurrent chemoradiation therapy at MD Anderson.
- Patients > or =18 years old
- Patients who will receive chemoradiation with platinum/taxane-based chemotherapy and with a total radiation dose of > 50 Gy, per treating physician's assessment
- Patients who speak English or Spanish (due to the novel research and its complexity, we are only accruing English or Spanish-speaking patients to the protocol)
- Patients must be willing and able to review, understand, and provide written consent before starting therapy
Who cannot join
- 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 who are enrolled in other symptom management or treatment 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, including multiple allergies or drug 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 upper limits of normal (ULN), according to MD Anderson testing standards, will be done by the oncologist to qualify for CXRT.
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- Patients with pre-existing hepatic impairment: The screening for total bilirubin >1.5 times ULN 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) (and aspartate aminotransferase [AST] if it is ordered and available in the medical records) will be done by the oncologist to qualify for CXRT.
- Patients with pre-existing Tourette's syndrome.
- Patients with hypersensitivity to any tetracyclines.
- Patients who are pregnant. Pregnancy will be confirmed by negative urine test. Study staff will provide the pregnancy kits to women and make sure the results are known and recorded in the follow-up notes in Clinic Station before additional study drug prescriptions are filled by the Pharmacy
- Patients with uncontrolled cardiac disease, within the past six months history of left ventricular hypertrophy, myocardial infarction, and history of mitral valve prolapse syndrome with previous central nervous system (CNS) stimulant use.
- Patients taking medicines that are strong CYP3A4 inhibitors or inducers (including conivaptan, indinavir, nelfinavir, ritonavir, nefazodone, and phenytoin), 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 Pilot Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung 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 symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.
Read the detailed description
The Study Drugs:
Armodafinil is designed to prevent excessive sleepiness.
Minocycline is an antibiotic. Minocycline has been shown to interrupt cytokine production, which may help to reduce multiple symptoms.
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 agree to take part in this study, you will be randomly assigned (as in the roll of dice) to join 1 of 4 groups.
- 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 placebos alone.
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, during this study, you may receive standard care by your treating doctors.
Study Drug Administration:
You will take the study drug(s)/placebos every day for 10 weeks. You should take the drug(s)/placebo(s) 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 drugs/placebos.
You should bring your study drug/placebo capsules to the clinic every study 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. You will complete the symptom questionnaire before you begin chemoradiation and then 1 time a week during Weeks 1-16 of the study. The symptom questionnaire will take up to 5 minutes to complete.
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.
- If you are 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 you can pick up the study drugs from the pharmacy. The pregnancy test will be repeated at weeks 1, 4, 7, and 12 (or at the first follow-up clinic visit post-treatment) and 30 days after the study drugs are stopped .
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 1 time a week to check on you until Week 10. This phone call should last only a few minutes. If you have had several side effects from chemoradiation, this phone call may take longer.
About Week 12 (or at the first routine follow-up clinic visit post-treatment):
- You will complete the 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 to complete.
- 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 Week 16. 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 excessive 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 12 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Lung Cancer
- Being tested
- Armodafinil, Placebo, Minocycline, Questionnaires
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Symptoms, Concurrent Chemoradiation, CXRT, Fatigue, Pain, Disturbed Sleep, Lack of Appetite, Drowsiness, Armodafinil, Nuvigil, Minocycline, Dynacin, Minocin, Minocin PAC, Myrac, Solodyn, Placebo
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Fatigue, Pain, Parasomnias, Anorexia, Sleepiness, 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 a 10 week cycle.
PlaceboOther
Also called Sugar Pill
Capsules taken by mouth once a day for a 10 week cycle.
MinocyclineDrug
Also called Dynacin, Minocin, Minocin PAC, Myrac
100 mg by mouth twice a day for a 10 week cycle.
QuestionnairesBehavioural
Also called Surveys
Completion of symptom questionnaire before chemoradiation, then once a week during Weeks 1-16, takes up to 5 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Armodafinil + Placebo | Experimental | Armodafinil orally 150 mg/day + Placebo capsules for 10 weeks Receives: Drug: Armodafinil; Other: Placebo; Behavioral: Questionnaires |
| Minocycline + Placebo | Experimental | Minocycline orally 100 mg twice/day + Placebo capsules for 10 weeks Receives: Other: Placebo; Drug: Minocycline; Behavioral: Questionnaires |
| Armodafinil + Minocycline | Experimental | Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks Receives: Drug: Armodafinil; Drug: Minocycline; Behavioral: Questionnaires |
| Placebos | Placebo comparator | Placebo Capsules orally once/day for 10 weeks Receives: Other: Placebo; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness
Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0*70) to 700 (10*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.
Measured: During 10 weeks of CXRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2016
- Study completionFeb 2016
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 Lung 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 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
- Zhongxing Liao, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317550
- Sponsor's protocol ID
- 2010-0872
- Other IDs
- R01 026582-26, NCI-2011-00778
- Status last verified
- Jan 2020
- First submitted
- 16 Mar 2011
- Last updated
- 10 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01317550
- Acronym / sponsor ID
- 2010-0872
- Conditions
- Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Symptoms, Concurrent Chemoradiation, CXRT, Fatigue, Pain, Disturbed Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Posted 10 Feb 2020
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 symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.
Detailed description
The Study Drugs:
Armodafinil is designed to prevent excessive sleepiness.
Minocycline is an antibiotic. Minocycline has been shown to interrupt cytokine production, which may help to reduce multiple symptoms.
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 agree to take part in this study, you will be randomly assigned (as in the roll of dice) to join 1 of 4 groups.
- 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 placebos alone.
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, during this study, you may receive standard care by your treating doctors.
Study Drug Administration:
You will take the study drug(s)/placebos every day for 10 weeks. You should take the drug(s)/placebo(s) 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 drugs/placebos.
You should bring your study drug/placebo capsules to the clinic every study 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. You will complete the symptom questionnaire before you begin chemoradiation and then 1 time a week during Weeks 1-16 of the study. The symptom questionnaire will take up to 5 minutes to complete.
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.
- If you are 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 you can pick up the study drugs from the pharmacy. The pregnancy test will be repeated at weeks 1, 4, 7, and 12 (or at the first follow-up clinic visit post-treatment) and 30 days after the study drugs are stopped .
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 1 time a week to check on you until Week 10. This phone call should last only a few minutes. If you have had several side effects from chemoradiation, this phone call may take longer.
About Week 12 (or at the first routine follow-up clinic visit post-treatment):
- You will complete the 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 to complete.
- 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 Week 16. 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 excessive 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 12 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Armodafinil + Placebo | Experimental | Drug: Armodafinil, Other: Placebo, Behavioral: QuestionnairesArmodafinil orally 150 mg/day + Placebo capsules for 10 weeks |
| Minocycline + Placebo | Experimental | Other: Placebo, Drug: Minocycline, Behavioral: QuestionnairesMinocycline orally 100 mg twice/day + Placebo capsules for 10 weeks |
| Armodafinil + Minocycline | Experimental | Drug: Armodafinil, Drug: Minocycline, Behavioral: QuestionnairesArmodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks |
| Placebos | Placebo comparator | Other: Placebo, Behavioral: QuestionnairesPlacebo Capsules orally once/day for 10 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a pathologically proven diagnosis of NSCLC and consented to concurrent chemoradiation therapy at MD Anderson.
- Patients > or =18 years old
- Patients who will receive chemoradiation with platinum/taxane-based chemotherapy and with a total radiation dose of > 50 Gy, per treating physician's assessment
- Patients who speak English or Spanish (due to the novel research and its complexity, we are only accruing English or Spanish-speaking patients to the protocol)
- Patients must be willing and able to review, understand, and provide written consent before starting therapy
Key exclusion criteria (13 listed)
- 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 who are enrolled in other symptom management or treatment 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, including multiple allergies or drug reaction as documented in the patient medical records
- Patients with pre-existing psychosis or bipolar disorder.
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 a 10 week cycle. | Drug | Armodafinil + Minocycline, Armodafinil + Placebo |
| PlaceboAlso: Sugar PillCapsules taken by mouth once a day for a 10 week cycle. | Other | Armodafinil + Placebo, Minocycline + Placebo, Placebos |
| MinocyclineAlso: Dynacin, Minocin, Minocin PAC, Myrac100 mg by mouth twice a day for a 10 week cycle. | Drug | Armodafinil + Minocycline, Minocycline + Placebo |
| QuestionnairesAlso: SurveysCompletion of symptom questionnaire before chemoradiation, then once a week during Weeks 1-16, takes up to 5 minutes to complete. | Behavioural | Armodafinil + Minocycline, Armodafinil + Placebo, Minocycline + Placebo, Placebos |
Primary outcome
Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness
Time frame: During 10 weeks of CXRT
Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0*70) to 700 (10*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- 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.
Zhongxing Liao, MD 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 study testing Armodafinil, Minocycline and Questionnaires in people with Lung 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 5 inclusion and 13 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 10 Feb 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2020). 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?
Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness (time frame: During 10 weeks of CXRT). 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 10 Feb 2020.