Oropharynx CancerPhase 2NCT01173692
Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.
A Phase 2 study testing Minocycline in people with Oropharynx 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 learn if minocycline can reduce the symptoms reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer of head and neck, who receive treatment with radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharynx Cancer
- What is being tested?
- Minocycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2010to 7 Jul 2020
- 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 oropharyngeal cancer, nasopharyngeal cancer, or unknown primary cancer of head and neck in MDACC receiving radiation therapy with or without induction chemotherapy.
- Patients > = 18 years old.
- Patients with the above cancers, T0, TX, T1 to T3, N any, M0 receiving IMRT (to unilateral or bilateral neck) at least 64-72 Gy in 6-7 weeks as definitive treatment.
- Patients must have normal renal function test and no prior renal disease: The screening cut off for serum creatinine < upper limit of normal.
- Patients must have normal hepatic function test and no prior liver disease: The screening results for total bilirubin must be < 1.5 times the upper limit of normal. The screening results for the following must be < 2 times the upper limit of normal for patients to be eligible: Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT). The screening results for Aspartate aminotransferase (AST) must be < 2 times the upper limit of normal if available.
- Patients who speak English (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol).
- Patients must be willing to discontinue taking dong quai and/or St John's wort.
- Patients must be willing and able to review, understand, and provide written consent.
Who cannot join
- Patients receiving concurrent chemotherapy or concurrent biologic agent.
- 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 another symptom management trial or receiving active treatment under another 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.
Show all 12Show fewer
- Hypersensitivity to any tetracyclines.
- Patients on anticoagulants (ie warfarin/heparin).
- Patients with INR > 1.5.
- Patients taking any tetracycline within the last 15 days.
- Patients that are pregnant.
- Patients treated with upfront radical surgery at the primary site (other than diagnostic tonsillectomy or excision).
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
The goal of this clinical research study is to learn if minocycline can reduce the symptoms reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer of head and neck, who receive treatment with radiation therapy.
Read the detailed description
The Study Drug:
Minocycline is an antibiotic and has been shown to interrupt cytokine production, which may help to reduce multiple symptoms.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take minocycline. Group 2 will take a placebo. A placebo is a substance that looks like the study drug but has no active ingredients.
Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Drug Administration:
You will take the study drug/placebo, by mouth, every day for 7 weeks starting at the first week of radiation therapy. You may take the study drug/placebo with a full glass (8 ounces) of water. You may take it with or without food. If it causes an upset stomach, you should take it with food. If you have trouble swallowing the dose of study drug/placebo, you can open the capsule right before you take them. You should not lie down for at least 30 minutes after taking the study drug/placebo to prevent possible irritation of the inside of the esophagus, a known side effect. You will be given pamphlets with more information about how to take the study drug/placebo.
You will be given a daily diary to write down what time you take the study drug/placebo. You must bring the diary with you to every study visit for the study doctor and research staff to review.
You must bring the study drug/placebo container to every study visit.
Study Visits:
Before you start your radiation treatment:
- You will have blood (about 2 teaspoons) drawn to check your liver function, if this test has not been done in the last 3 months.
- If you are able to become pregnant, you will have a urine pregnancy test. The study staff will give you the pregnancy test kit, and will review and record the results of the test before you can pick up the study drug from the pharmacy. If you are pregnant, you will not be given the study drug.
- You will also complete 5 questionnaires about pain and other symptoms, your alcohol and tobacco history, your health status, and your quality of life. It should take about 15 minutes to complete all of the questionnaires.
During radiation treatment (approximately Weeks 1- 7 of radiation):
You will complete the symptom questionnaire in the clinic or by telephone 2 times a week. You will be asked about symptoms you may be experiencing and how they may be interfering with your normal daily activities. You will complete the symptom questionnaire during one of your regular clinic visits. If you do not have a clinic visit scheduled around the time that the questionnaire needs to be completed, a member of the study staff will call you at your home at a time that is convenient for you. The symptom questionnaire should take about 5 minutes to complete each time.
At about Week 4 of radiation, you will complete 4 additional questionnaires about pain and other symptoms, your tobacco use, and a quality of life questionnaire. It should take about 5 minutes to complete all of the questionnaires.
During the last week of radiation (about Week 6-7), you will complete 4 additional questionnaires about pain and other symptoms, your health status, and your quality of life. It should take about 10 minutes to complete all of the questionnaires.
Starting after the last week of radiation (about Weeks 7-10), the study staff will call you 2 times each week to check on you. This phone call should last about 5 minutes. If you have had several side effects from the radiation therapy, this phone call may take longer.
Follow-Up Phone Calls:
During Weeks 11-15, you will complete the pain and other symptoms questionnaire 1 time a week by phone. A member of the study staff will call you at your home at a time that is convenient for you. The symptom questionnaire should take about 5 minutes to complete by phone each time.
End of Study Visit:
Your last study visit will be the same day that you have your last clinic visit with the radiation doctor (around Weeks 13-15). At this visit, you will complete the pain and other symptoms questionnaire, your health status and the 2 smoking questionnaires. It should take about 5 minutes to complete both questionnaires.
Length of Study:
You will be on study for up to 15 weeks. You will take the study drug/placebo for up to 7 weeks and continue to complete the symptom survey until 15 weeks. You will be taken off study early if you experience intolerable side effects or the study doctor thinks it is in your best interest.
This is an investigational study. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. Using minocycline for the treatment of the symptoms of radiation treatment for oropharynx cancer, nasopharynx cancer, or unknown primary cancer of head and neck, is investigational.
Up to 60 patients will take part in this research study. All will be enrolled at MD Anderson main campus as well as the regional care centers.
- Conditions
- Oropharynx Cancer
- Being tested
- Minocycline, Placebo
- Keywords
- Oropharynx Cancer, Radiation Therapy, XRT, Radiotherapy, Minocycline, Symptoms, Head and Neck
- Medical subject headings
- Oropharyngeal Neoplasms, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called Dynacin, Minocin, Minocin PAC, Myrac
100 mg twice daily (200 mg) by mouth , every day for 7 weeks starting first day of radiation therapy.
PlaceboDrug
Also called Sugar Pill
Twice daily by mouth, every day for 7 weeks starting at first day of radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Twice Daily Orally Receives: Drug: Placebo |
| Minocycline | Experimental | 100 mg Twice Daily Orally Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined AUC for Selected Patient Symptoms
7-week (+/- 5 days) average area under the curve (AUC) for select MD Anderson Symptom Inventory for head and neck cancer (MDASI-HNC) symptoms namely fatigue, pain, sleep disturbance, difficulty swallowing and lack of appetite reported in the symptom survey. Each item is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine). Higher values represent a worse outcome.
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study start22 Jul 2010
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
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 Oropharynx 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 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
- Gary B. Gunn, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173692
- Sponsor's protocol ID
- 2010-0096
- Other IDs
- CA07, NCI-2012-01783
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2010
- Last updated
- 20 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.
- ClinicalTrials.gov ID
- NCT01173692
- Acronym / sponsor ID
- 2010-0096
- Conditions
- Oropharynx Cancer
- Keywords
- Oropharynx Cancer, Radiation Therapy, XRT, Radiotherapy, Minocycline, Symptoms, Head and Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Jul 2010 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 2 Aug 2010 (estimated)
- Results
- Posted 20 Aug 2021
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 learn if minocycline can reduce the symptoms reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer of head and neck, who receive treatment with radiation therapy.
Detailed description
The Study Drug:
Minocycline is an antibiotic and has been shown to interrupt cytokine production, which may help to reduce multiple symptoms.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take minocycline. Group 2 will take a placebo. A placebo is a substance that looks like the study drug but has no active ingredients.
Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Drug Administration:
You will take the study drug/placebo, by mouth, every day for 7 weeks starting at the first week of radiation therapy. You may take the study drug/placebo with a full glass (8 ounces) of water. You may take it with or without food. If it causes an upset stomach, you should take it with food. If you have trouble swallowing the dose of study drug/placebo, you can open the capsule right before you take them. You should not lie down for at least 30 minutes after taking the study drug/placebo to prevent possible irritation of the inside of the esophagus, a known side effect. You will be given pamphlets with more information about how to take the study drug/placebo.
You will be given a daily diary to write down what time you take the study drug/placebo. You must bring the diary with you to every study visit for the study doctor and research staff to review.
You must bring the study drug/placebo container to every study visit.
Study Visits:
Before you start your radiation treatment:
- You will have blood (about 2 teaspoons) drawn to check your liver function, if this test has not been done in the last 3 months.
- If you are able to become pregnant, you will have a urine pregnancy test. The study staff will give you the pregnancy test kit, and will review and record the results of the test before you can pick up the study drug from the pharmacy. If you are pregnant, you will not be given the study drug.
- You will also complete 5 questionnaires about pain and other symptoms, your alcohol and tobacco history, your health status, and your quality of life. It should take about 15 minutes to complete all of the questionnaires.
During radiation treatment (approximately Weeks 1- 7 of radiation):
You will complete the symptom questionnaire in the clinic or by telephone 2 times a week. You will be asked about symptoms you may be experiencing and how they may be interfering with your normal daily activities. You will complete the symptom questionnaire during one of your regular clinic visits. If you do not have a clinic visit scheduled around the time that the questionnaire needs to be completed, a member of the study staff will call you at your home at a time that is convenient for you. The symptom questionnaire should take about 5 minutes to complete each time.
At about Week 4 of radiation, you will complete 4 additional questionnaires about pain and other symptoms, your tobacco use, and a quality of life questionnaire. It should take about 5 minutes to complete all of the questionnaires.
During the last week of radiation (about Week 6-7), you will complete 4 additional questionnaires about pain and other symptoms, your health status, and your quality of life. It should take about 10 minutes to complete all of the questionnaires.
Starting after the last week of radiation (about Weeks 7-10), the study staff will call you 2 times each week to check on you. This phone call should last about 5 minutes. If you have had several side effects from the radiation therapy, this phone call may take longer.
Follow-Up Phone Calls:
During Weeks 11-15, you will complete the pain and other symptoms questionnaire 1 time a week by phone. A member of the study staff will call you at your home at a time that is convenient for you. The symptom questionnaire should take about 5 minutes to complete by phone each time.
End of Study Visit:
Your last study visit will be the same day that you have your last clinic visit with the radiation doctor (around Weeks 13-15). At this visit, you will complete the pain and other symptoms questionnaire, your health status and the 2 smoking questionnaires. It should take about 5 minutes to complete both questionnaires.
Length of Study:
You will be on study for up to 15 weeks. You will take the study drug/placebo for up to 7 weeks and continue to complete the symptom survey until 15 weeks. You will be taken off study early if you experience intolerable side effects or the study doctor thinks it is in your best interest.
This is an investigational study. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. Using minocycline for the treatment of the symptoms of radiation treatment for oropharynx cancer, nasopharynx cancer, or unknown primary cancer of head and neck, is investigational.
Up to 60 patients will take part in this research study. All will be enrolled at MD Anderson main campus as well as the regional care centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboTwice Daily Orally |
| Minocycline | Experimental | Drug: Minocycline100 mg Twice Daily Orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with a pathologically proven diagnosis of oropharyngeal cancer, nasopharyngeal cancer, or unknown primary cancer of head and neck in MDACC receiving radiation therapy with or without induction chemotherapy.
- Patients > = 18 years old.
- Patients with the above cancers, T0, TX, T1 to T3, N any, M0 receiving IMRT (to unilateral or bilateral neck) at least 64-72 Gy in 6-7 weeks as definitive treatment.
- Patients must have normal renal function test and no prior renal disease: The screening cut off for serum creatinine < upper limit of normal.
- Patients must have normal hepatic function test and no prior liver disease: The screening results for total bilirubin must be < 1.5 times the upper limit of normal. The screening results for the following must be < 2 times the upper limit of normal for patients to be eligible: Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT). The screening results for Aspartate aminotransferase (AST) must be < 2 times the upper limit of normal if available.
Key exclusion criteria (12 listed)
- Patients receiving concurrent chemotherapy or concurrent biologic agent.
- 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 another symptom management trial or receiving active treatment under another 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 |
|---|---|---|
| MinocyclineAlso: Dynacin, Minocin, Minocin PAC, Myrac100 mg twice daily (200 mg) by mouth , every day for 7 weeks starting first day of radiation therapy. | Drug | Minocycline |
| PlaceboAlso: Sugar PillTwice daily by mouth, every day for 7 weeks starting at first day of radiation therapy. | Drug | Placebo |
Primary outcome
Combined AUC for Selected Patient Symptoms
Time frame: Up to 7 weeks
7-week (+/- 5 days) average area under the curve (AUC) for select MD Anderson Symptom Inventory for head and neck cancer (MDASI-HNC) symptoms namely fatigue, pain, sleep disturbance, difficulty swallowing and lack of appetite reported in the symptom survey. Each item is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine). Higher values represent a worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- 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.
Gary B. Gunn, 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 Phase 2 study testing Minocycline in people with Oropharynx 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 12 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 20 Aug 2021. 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 20 Aug 2021). 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?
Combined AUC for Selected Patient Symptoms (time frame: Up to 7 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 20 Aug 2021.