Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.
Condition: Oropharynx Cancer
MeSH terms: Oropharyngeal Neoplasms
Intervention: Minocycline; Placebo
Intervention description: 100 mg twice daily (200 mg) by mouth , every day for 7 weeks starting first day of radiation therapy.; Twice daily by mouth, every day for 7 weeks starting at first day of radiation therapy.
Intervention MeSH terms: Minocycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oropharynx Cancer; Radiation Therapy; XRT; Radiotherapy; Minocycline; Symptoms; Head and Neck

Summary:

      The goal of this clinical research study is to learn if minocycline can reduce the symptoms
      reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer of
      head and neck, who receive treatment with radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a pathologically proven diagnosis of oropharyngeal cancer,
             nasopharyngeal cancer, or unknown primary cancer of head and neck in MDACC receiving
             radiation therapy with or without induction chemotherapy.

          2. Patients > = 18 years old.

          3. Patients with the above cancers, T0, TX, T1 to T3, N any, M0 receiving IMRT (to
             unilateral or bilateral neck) at least 64-72 Gy in 6-7 weeks as definitive treatment.

          4. Patients must have normal renal function test and no prior renal disease: The
             screening cut off for serum creatinine < upper limit of normal.

          5. Patients must have normal hepatic function test and no prior liver disease: The
             screening results for total bilirubin must be < 1.5 times the upper limit of normal.
             The screening results for the following must be < 2 times the upper limit of normal
             for patients to be eligible: Alkaline phosphatase (ALP) and Alanine aminotransferase
             (ALT). The screening results for Aspartate aminotransferase (AST) must be < 2 times
             the upper limit of normal if available.

          6. Patients who speak English (due to the novel research and its complexity, we are only
             accruing English speaking patients to the protocol).

          7. Patients must be willing to discontinue taking dong quai and/or St John's wort.

          8. Patients must be willing and able to review, understand, and provide written consent.

        Exclusion Criteria:

          1. Patients receiving concurrent chemotherapy or concurrent biologic agent.

          2. Patients who are taking medications or have conditions that potentially preclude use
             of any study medications or interventions as determined by the treating physician.

          3. Patients who are enrolled in another symptom management trial or receiving active
             treatment under another clinical trial.

          4. Bile duct obstruction or cholelithiasis.

          5. History of clinically significant cutaneous drug reaction, or a history of clinically
             significant hypersensitivity reaction, including multiple allergies or drug reaction.

          6. Pre-existing psychosis or bipolar disorder.

          7. Hypersensitivity to any tetracyclines.

          8. Patients on anticoagulants (ie warfarin/heparin).

          9. Patients with INR > 1.5.

         10. Patients taking any tetracycline within the last 15 days.

         11. Patients that are pregnant.

         12. Patients treated with upfront radical surgery at the primary site (other than
             diagnostic tonsillectomy or excision).