Head And Neck CancerPhase 1/2NCT01219673
Symptom Burden in Head and Neck Cancer
A Phase 1/2 study testing Armodafinil, Minocycline and Bupropion in people with Head And Neck 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, 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Head And Neck Cancer
- What is being tested?
- Armodafinil, Minocycline and Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jan 2014
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Head and Neck Cancer
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.
Read the 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.
- Conditions
- Head And Neck Cancer
- Being tested
- Placebo, Armodafinil, Minocycline, Bupropion
- Keywords
- Epithelial carcinoma, Oropharynx, Larynx, Symptom-management, Chemoradiation, Placebo, Armodafinil, Nuvigil, Bupropion, Wellbutrin, Wellbutrin SR, Zyban, Minocycline, Dynacin, Minocin, Minocin PAC, Myrac, Solodyn
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Laryngeal Diseases, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
1 by mouth twice a day.
ArmodafinilDrug
Also called Nuvigil
150 mg by mouth once a day.
MinocyclineDrug
Also called Dynacin, Minocin, Minocin PAC, Myrac
100 mg by mouth twice a day.
BupropionDrug
Also called Wellbutrin, Wellbutrin SR, Zyban
100 mg by mouth twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo by mouth 2 times every day. Receives: Other: Placebo |
| Armodafinil | Experimental | Armodafinil 150 mg by mouth once a day. Receives: Drug: Armodafinil |
| Minocycline | Experimental | Minocycline 100 mg by muth two times a day. Receives: Drug: Minocycline |
| Bupropion | Experimental | Bupropion 100 mg by mouth two times a day. Receives: Drug: Bupropion |
| Armodafinil + Minocycline | Experimental | Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by mouth two times a day. Receives: Drug: Armodafinil; Drug: Minocycline |
| Armodafinil + Bupropion | Experimental | Armodafinil 150 mg by mouth once a day.
Bupropion 100 mg by mouth two times a day. Receives: Drug: Armodafinil; Drug: Bupropion |
| Minocycline + Bupropion | Experimental | Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day. Receives: Drug: Minocycline; Drug: Bupropion |
| Armodafinil + Minocycline + Bupropion | Experimental | 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. Receives: Drug: Armodafinil; Drug: Minocycline; Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Effects on 5 Selected Symptoms (Average MDASI-HNC Scores)
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Low accrual.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head And Neck 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 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
- David I. Rosenthal, MD, MA, BA, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219673
- Sponsor's protocol ID
- 2009-0517
- Other IDs
- R01 026582-26
- Status last verified
- Jan 2015
- First submitted
- 11 Oct 2010
- Last updated
- 10 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4.
PubMed 36999619
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01219673
- Acronym / sponsor ID
- 2009-0517
- Conditions
- Head And Neck Cancer
- Keywords
- Epithelial carcinoma, Oropharynx, Larynx, Symptom-management, Chemoradiation, Placebo, Armodafinil, Nuvigil
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Posted 10 Feb 2015
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, 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo by mouth 2 times every day. |
| Armodafinil | Experimental | Drug: ArmodafinilArmodafinil 150 mg by mouth once a day. |
| Minocycline | Experimental | Drug: MinocyclineMinocycline 100 mg by muth two times a day. |
| Bupropion | Experimental | Drug: BupropionBupropion 100 mg by mouth two times a day. |
| Armodafinil + Minocycline | Experimental | Drug: Armodafinil, Drug: MinocyclineArmodafinil 150 mg by mouth once a day. Minocycline 100 mg by mouth two times a day. |
| Armodafinil + Bupropion | Experimental | Drug: Armodafinil, Drug: BupropionArmodafinil 150 mg by mouth once a day. Bupropion 100 mg by mouth two times a day. |
| Minocycline + Bupropion | Experimental | Drug: Minocycline, Drug: BupropionMinocycline 100 mg by muth two times a day. Bupropion 100 mg by mouth two times a day. |
| Armodafinil + Minocycline + Bupropion | Experimental | Drug: Armodafinil, Drug: Minocycline, Drug: BupropionArmodafinil 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (22 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 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
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 |
|---|---|---|
| Placebo1 by mouth twice a day. | Other | Placebo |
| ArmodafinilAlso: Nuvigil150 mg by mouth once a day. | Drug | Armodafinil, Armodafinil + Bupropion, Armodafinil + Minocycline, Armodafinil + Minocycline + Bupropion |
| MinocyclineAlso: Dynacin, Minocin, Minocin PAC, Myrac100 mg by mouth twice a day. | Drug | Armodafinil + Minocycline, Armodafinil + Minocycline + Bupropion, Minocycline, Minocycline + Bupropion |
| BupropionAlso: Wellbutrin, Wellbutrin SR, Zyban100 mg by mouth twice a day. | Drug | Armodafinil + Bupropion, Armodafinil + Minocycline + Bupropion, Bupropion, Minocycline + Bupropion |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36999619Vita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4.
- UT 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.
David I. Rosenthal, MD, MA, BA principal investigator
UT MD 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 1/2 study testing Armodafinil, Minocycline and Bupropion in people with Head And Neck 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 8 inclusion and 22 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: stopped early, as of the sponsor's last update on 10 Feb 2015. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 10 Feb 2015). 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?
Treatment Effects on 5 Selected Symptoms (Average MDASI-HNC Scores) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01219673, which also lists 1 linked publication.
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 2015.