Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer
Condition: Head And Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Minocycline; Placebo; Questionnaires
Intervention description: 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.; Placebo 100 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.
Intervention MeSH terms: Minocycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head And Neck Cancer; Postsurgical symptom reduction; Minocycline; Dynacin; Minocin; Minocin PAC; Myrac; Solodyn; Placebo; Sugar pill; Questionnaires; Surveys

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.
    

Eligibility criteria:

        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.