Head And Neck CancerPhase 2NCT02055963
Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer
A Phase 2 study testing Minocycline and Questionnaires 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 learn if Minocin® (minocycline) can reduce certain side effects of surgery in patients with head and neck cancer (such as pain, fatigue, and disturbed sleep). In this study, minocycline will be compared to a placebo. A placebo is not a drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head And Neck Cancer
- What is being tested?
- 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2014to 11 Aug 2022
- 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 head and neck cancer who are undergoing either flap or nonflap surgery (limited to parotidectomy, hard palate maxillectomy and glossectomy, mandibulectomy, and any procedure with neck dissection) at MD Anderson Cancer Center.
- Patients > 18 years old.
- Patients who have not undergone surgery in the past 6 months. Patients may have had neoadjuvant chemotherapy prior to surgery.
- Patients must have normal renal function test and no prior renal disease. The screening cut off for serum creatinine is < 1.5mg/dL.
- Patients must have normal hepatic function test and no prior liver disease: (1) The screening results for alanine aminotransferase (ALT) must be < 2 times the upper limit of normal. (2) The screening results for aspartate aminotransferase (AST), if available, must be < 2 times the upper limit of normal.
- Patients who speak English or Spanish (due to the novel research and its complexity, we are only accruing English-speaking or Spanish-speaking patients to the protocol).
- Patients must be willing and able to review, understand, and provide written consent.
- Patients must be willing to discontinue taking dong quai and/or St. John's wort.
Who cannot join
- Patients who are taking medications (including minocycline) or have conditions that potentially preclude use of the study medication or intervention as determined by the treating physician.
- Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial.
- Patients with a history of clinically significant cutaneous drug reaction, hypersensitivity reaction, anaphylaxis or any other serious adverse reaction to any of the anesthetics or analgesics medications used in the study.
- Patients with hypersensitivity to any tetracycline.
- Patients on vitamin K antagonist (i.e., warfarin).
- Patients taking any tetracycline within the last 15 days.
Show all 11Show fewer
- Patients who have been on opioid therapy for the last 4 weeks or more.
- Patients with bile duct obstruction.
- Patients who are pregnant.
- Patients with INR > 1.5.
- Patients with autoimmune disease.
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: Minocycline for Reduction of Symptom Burden After Surgery in Patients With Head and Neck Malignancy: A Randomized Study
The goal of this clinical research study is to learn if Minocin® (minocycline) can reduce certain side effects of surgery in patients with head and neck cancer (such as pain, fatigue, and disturbed sleep). In this study, minocycline will be compared to a placebo.
A placebo is not a drug. It looks like the study drug, but it 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 found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being in any group.
- If you are in Group 1, you will receive minocycline.
- If you are in Group 2, you will receive a placebo.
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 minocycline/placebo 2 times every day (about 12 hours apart). This will be from 1-2 days before surgery until 3 weeks after surgery.
Most of the time, you will take the minocycline/placebo by mouth or through your feeding tube. If you are unable to take it by mouth or through your feeding tube, you will receive it by vein every 12 hours.
You should take the study drug/placebo with a full glass (8 ounces) of water. You may take it with or without food, but if it causes an upset stomach, you should take it with food.
You should not lie down for at least 30 minutes after taking the study drug/placebo to reduce the risk of side effects.
You will also be given standard drugs to help decrease the risk of side effects from the surgery. You may ask the study staff for information about how the drugs are given and their risks.
Study Visits:
After you agree to participate in the study, on the day of surgery, 1 and 3 days after surgery, and then about 2 times a week until the end of the study, you will complete a questionnaire about any side effects you are experiencing. This should take about 5 minutes to complete. When you are at home, you will complete this questionnaire over the phone through a computerized system. You will answer the questions using your telephone keypad.
After you agree to participate in the study, and at 1 and 3 days after surgery, you will complete 2 questionnaires about your quality of life. This should take about 10 minutes to complete.
After you agree to participate in the study, soon after your surgery, and 1 week after surgery or when you are discharged from the hospital, saliva will be collected and used to test for markers of inflammation. If possible, blood (about 2 teaspoons) also will be drawn to test for markers of inflammation. This will be during a regular blood draw and you would not need to have an extra needle stick.
Length of Study:
You will take the study drug/placebo for 3 weeks after surgery. You will no longer be able to take the study drug/placebo if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visit.
Follow up Visit:
At about 3 weeks after your surgery, you will return to the clinic. The following tests and procedures will be performed:
- Saliva will be collected and used to test for markers of inflammation.
- You will complete 3 questionnaires about your quality of life and any side effects you are feeling. This should take about 20 minutes to complete.
- If possible, blood (about 2 teaspoons) also will be drawn to test for markers of inflammation. This will be during a regular blood draw and you would not need to have an extra needle stick.
This is an investigational study. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. Using minocycline to try to reduce the side effects of surgery in patients with head and neck cancer is investigational.
Up to 130 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Head And Neck Cancer
- Being tested
- Minocycline, Placebo, Questionnaires
- Keywords
- Head And Neck Cancer, Postsurgical symptom reduction, Minocycline, Dynacin, Minocin, Minocin PAC, Myrac, Solodyn, Placebo, Sugar pill, Questionnaires, Surveys
- Medical subject headings
- Head and Neck 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 given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
PlaceboDrug
Also called Sugar pill
Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
QuestionnairesBehavioural
Also called Surveys
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Minocycline100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21. Receives: Drug: Minocycline; Behavioral: Questionnaires |
| Placebo | Placebo comparator | Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery).
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21. Receives: Drug: Placebo; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Minocycline for Reducing Patient-Reported Symptoms
Primary outcome variable is area under the curve (AUC) using the average of the 3 most severe symptoms (pain, fatigue, and disturbed sleep) beginning 2 days prior to surgery and ending 21 days postsurgery. AUC calculated using trapezoidal approximation. The base of a trapezoid corresponds to the number of days between assessments while the heights correspond to 2 adjoining symptom responses. The number of trapezoids depends on the number of symptom assessments. The sum of the area for all the trapezoids represents the AUC of a particular patient. Data were collected to create the curve (-2, 0, 1, 3, 5, 7, 10, 14, 17, and 21 days post-dose)
Measured: -2 to 21 days post-dose
Secondary outcomes (1)
Number of Participants Time-to-Symptom-Recovery
Time-to-symptom-recovery defined to be the time it takes for symptom severity (average of pain, fatigue and disturbed sleep) to return to preoperative levels for 2 consecutive assessments. Repeated measures ANOVA performed with group (minocycline vs. placebo), time (presurgery, postsurgery, discharge, follow up) and group-by-time interaction as factors and proinflammatory cytokine level as a dependent variable. Data measured at Day -2, Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, Day 20. Cox proportional hazards models were used to explore predictors of time-to-symptom-recovery.
Measured: Day -2, Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study start6 May 2014
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Why it stopped: Early termination due to the protocol lack of progress in improving accrual rate
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 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- Juan P. Cata, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055963
- Sponsor's protocol ID
- 2013-0510
- Other IDs
- R01CA026582, NCI-2014-01979
- Status last verified
- Oct 2022
- First submitted
- 4 Feb 2014
- Last updated
- 20 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minocycline for Reduction of Symptom Burden After Surgery in Patients With Head and Neck Malignancy: A Randomized Study
- ClinicalTrials.gov ID
- NCT02055963
- Acronym / sponsor ID
- 2013-0510
- Conditions
- Head And Neck Cancer
- Keywords
- Head And Neck Cancer, Postsurgical symptom reduction, Minocycline, Dynacin, Minocin, Minocin PAC, Myrac, Solodyn
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to the protocol lack of progress in improving accrual rate
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 May 2014 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Posted 18 Oct 2022
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 Minocin® (minocycline) can reduce certain side effects of surgery in patients with head and neck cancer (such as pain, fatigue, and disturbed sleep). In this study, minocycline will be compared to a placebo.
A placebo is not a drug. It looks like the study drug, but it 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 found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being in any group.
- If you are in Group 1, you will receive minocycline.
- If you are in Group 2, you will receive a placebo.
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 minocycline/placebo 2 times every day (about 12 hours apart). This will be from 1-2 days before surgery until 3 weeks after surgery.
Most of the time, you will take the minocycline/placebo by mouth or through your feeding tube. If you are unable to take it by mouth or through your feeding tube, you will receive it by vein every 12 hours.
You should take the study drug/placebo with a full glass (8 ounces) of water. You may take it with or without food, but if it causes an upset stomach, you should take it with food.
You should not lie down for at least 30 minutes after taking the study drug/placebo to reduce the risk of side effects.
You will also be given standard drugs to help decrease the risk of side effects from the surgery. You may ask the study staff for information about how the drugs are given and their risks.
Study Visits:
After you agree to participate in the study, on the day of surgery, 1 and 3 days after surgery, and then about 2 times a week until the end of the study, you will complete a questionnaire about any side effects you are experiencing. This should take about 5 minutes to complete. When you are at home, you will complete this questionnaire over the phone through a computerized system. You will answer the questions using your telephone keypad.
After you agree to participate in the study, and at 1 and 3 days after surgery, you will complete 2 questionnaires about your quality of life. This should take about 10 minutes to complete.
After you agree to participate in the study, soon after your surgery, and 1 week after surgery or when you are discharged from the hospital, saliva will be collected and used to test for markers of inflammation. If possible, blood (about 2 teaspoons) also will be drawn to test for markers of inflammation. This will be during a regular blood draw and you would not need to have an extra needle stick.
Length of Study:
You will take the study drug/placebo for 3 weeks after surgery. You will no longer be able to take the study drug/placebo if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visit.
Follow up Visit:
At about 3 weeks after your surgery, you will return to the clinic. The following tests and procedures will be performed:
- Saliva will be collected and used to test for markers of inflammation.
- You will complete 3 questionnaires about your quality of life and any side effects you are feeling. This should take about 20 minutes to complete.
- If possible, blood (about 2 teaspoons) also will be drawn to test for markers of inflammation. This will be during a regular blood draw and you would not need to have an extra needle stick.
This is an investigational study. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. Using minocycline to try to reduce the side effects of surgery in patients with head and neck cancer is investigational.
Up to 130 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: Minocycline, Behavioral: QuestionnairesParticipants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery. Minocycline100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery. Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21. |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: QuestionnairesParticipants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery. Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery). Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21. |
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 head and neck cancer who are undergoing either flap or nonflap surgery (limited to parotidectomy, hard palate maxillectomy and glossectomy, mandibulectomy, and any procedure with neck dissection) at MD Anderson Cancer Center.
- Patients > 18 years old.
- Patients who have not undergone surgery in the past 6 months. Patients may have had neoadjuvant chemotherapy prior to surgery.
- Patients must have normal renal function test and no prior renal disease. The screening cut off for serum creatinine is < 1.5mg/dL.
- Patients must have normal hepatic function test and no prior liver disease: (1) The screening results for alanine aminotransferase (ALT) must be < 2 times the upper limit of normal. (2) The screening results for aspartate aminotransferase (AST), if available, must be < 2 times the upper limit of normal.
Key exclusion criteria (11 listed)
- Patients who are taking medications (including minocycline) or have conditions that potentially preclude use of the study medication or intervention as determined by the treating physician.
- Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial.
- Patients with a history of clinically significant cutaneous drug reaction, hypersensitivity reaction, anaphylaxis or any other serious adverse reaction to any of the anesthetics or analgesics medications used in the study.
- Patients with hypersensitivity to any tetracycline.
- Patients on vitamin K antagonist (i.e., warfarin).
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 given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery. | Drug | Minocycline |
| PlaceboAlso: Sugar pillPlacebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery. | Drug | Placebo |
| QuestionnairesAlso: SurveysQuestionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21. | Behavioural | Minocycline, Placebo |
Primary outcome
Efficacy of Minocycline for Reducing Patient-Reported Symptoms
Time frame: -2 to 21 days post-dose
Primary outcome variable is area under the curve (AUC) using the average of the 3 most severe symptoms (pain, fatigue, and disturbed sleep) beginning 2 days prior to surgery and ending 21 days postsurgery. AUC calculated using trapezoidal approximation. The base of a trapezoid corresponds to the number of days between assessments while the heights correspond to 2 adjoining symptom responses. The number of trapezoids depends on the number of symptom assessments. The sum of the area for all the trapezoids represents the AUC of a particular patient. Data were collected to create the curve (-2, 0, 1, 3, 5, 7, 10, 14, 17, and 21 days post-dose)
1 secondary outcome
Number of Participants Time-to-Symptom-Recovery
Time frame: Day -2, Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, Day 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- 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.
Juan P. Cata, 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 and Questionnaires 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 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: stopped early, as of the sponsor's last update on 20 Oct 2022. 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 18 Oct 2022). 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?
Efficacy of Minocycline for Reducing Patient-Reported Symptoms (time frame: -2 to 21 days post-dose). 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 Oct 2022.