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Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055963
Recruitment Status : Active, not recruiting
First Posted : February 5, 2014
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE February 4, 2014
First Posted Date  ICMJE February 5, 2014
Last Update Posted Date July 12, 2019
Actual Study Start Date  ICMJE May 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
Efficacy of Minocycline for Reducing Patient-Reported Symptoms [ Time Frame: 21 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2014)
Time-to-Symptom-Recovery [ Time Frame: 2 weeks after surgery ]
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. Rate of change calculated in symptom severity for 2 weeks postsurgery and its relationship determined with proinflammatory cytokine levels and damage-associated molecular patterns (DAMPS) immediately after surgery. Paired t-test used to determine whether there is a significant increase in DAMPS before and after surgery.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
Time-to-Symptom-Recovery [ Time Frame: 2 weeks after surgery ]
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. We will perform repeated measures ANOVA 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. Rate of change calculated in symptom severity for 2 weeks postsurgery and its relationship determined with proinflammatory cytokine levels and damage-associated molecular patterns (DAMPS) immediately after surgery. Paired t-test used to determine whether there is a significant increase in DAMPS before and after surgery.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer
Official Title  ICMJE Minocycline for Reduction of Symptom Burden After Surgery in Patients With Head and Neck Malignancy: A Randomized Study
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Head And Neck Cancer
Intervention  ICMJE
  • Drug: Minocycline
    100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
    Other Names:
    • Dynacin
    • Minocin
    • Minocin PAC
    • Myrac
    • Solodyn
  • Drug: Placebo
    Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
    Other Name: Sugar pill
  • Behavioral: Questionnaires
    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.
    Other Name: Surveys
Study Arms  ICMJE
  • Experimental: 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.

    Interventions:
    • Drug: Minocycline
    • Behavioral: Questionnaires
  • Placebo Comparator: 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.

    Interventions:
    • Drug: Placebo
    • Behavioral: Questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 16, 2016)
30
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2014)
130
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. Patients > 18 years old.
  3. Patients who have not undergone surgery in the past 6 months. Patients may have had neoadjuvant chemotherapy prior to surgery.
  4. Patients must have normal renal function test and no prior renal disease. The screening cut off for serum creatinine is < 1.5mg/dL.
  5. 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.
  6. 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).
  7. Patients must be willing and able to review, understand, and provide written consent.
  8. Patients must be willing to discontinue taking dong quai and/or St. John's wort.

Exclusion Criteria:

  1. 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.
  2. Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial.
  3. 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.
  4. Patients with hypersensitivity to any tetracycline.
  5. Patients on vitamin K antagonist (i.e., warfarin).
  6. Patients taking any tetracycline within the last 15 days.
  7. Patients who have been on opioid therapy for the last 4 weeks or more.
  8. Patients with bile duct obstruction.
  9. Patients who are pregnant.
  10. Patients with INR > 1.5.
  11. Patients with autoimmune disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02055963
Other Study ID Numbers  ICMJE 2013-0510
R01CA026582 ( U.S. NIH Grant/Contract )
NCI-2014-01979 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Juan P. Cata, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP