Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Minocycline

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.