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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA026582 | U.S. NIH Grant/Contract | View source | |
| NCI-2014-01979 | Registry Identifier | NCI CTRP |
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Early termination due to the protocol lack of progress in improving accrual rate
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline | Drug | 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | -2 to 21 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan P. Cata, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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All participants enrolled at MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Minocycline | 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. |
| FG001 | Placebo | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Minocycline | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 4 participants were not included in the primary efficacy analysis due to 3 dropped out before 1 week (1 in the Minocycline Arm and 2 in the Placebo Arm) and 1 participants in the Minocycline Arm the MD Anderson Symptom Inventory (MDASI) was not evaluated. | Posted | Mean | Standard Deviation | mcg*hr/mL | -2 to 21 days post-dose |
|
From the first dose through 30 days after the last dose of study drug medication, up to week 6 ± 1 week post-surgery (in clinic or by phone)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Minocycline | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
Early termination due to the protocol lack of progress in improving accrual rate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juan P. Cata, MD-Associate Professor, Anesthesiology & PeriOper Med | UT MD Anderson Cancer Center | (713) 792-7452 | jcata@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2016 | Aug 18, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| C562573 | cyclopia sequence |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| D000073893 | Sugars |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery. |
|
|
| Questionnaires | Behavioral | 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. |
|
|
| Day -2, Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, Day 20 |
| BG001 | Placebo | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Minocycline |
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. |
| OG001 | Placebo | 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. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Day -2, Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, Day 20 |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 4 |
| 14 |
| EG001 | Placebo | 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. | 0 | 16 | 1 | 16 | 1 | 16 |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hives | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Itchy | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lack of appetite | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D002241 | Carbohydrates |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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