A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: Armodafinil; Placebo; Minocycline; Questionnaires
Intervention description: 150 mg by mouth once a day for 6 weeks.; 1 capsule by mouth 2 times a day for 6 weeks.; 100 mg by mouth 2 times a day for 6 weeks.; Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.
Intervention MeSH terms: Minocycline; Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Esophageal cancer; Chemotherapy; Radiation therapy; XRT; Chemoradiation; CXRT; Symptom Burden; Armodafinil; Nuvigil; Minocycline; Dynacin; Minocin; Minocin PAC; Myrac; Solodyn; Placebo; Sugar pill; Questionnaires; Surveys

Summary:

      The goal of this clinical research study is to compare armodafinil and minocycline when given
      alone or in combination to learn which is better for controlling side effects of
      chemoradiation treatment for esophageal cancer (such as fatigue, pain, disturbed sleep, lack
      of appetite, and drowsiness).

      Armodafinil is designed to prevent excessive sleepiness.

      Minocycline is an antibiotic, which may help to reduce multiple symptoms.

      In this study, you may receive a placebo. A placebo is not a drug. It looks like the study
      drug but 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 a pathologically proven diagnosis of esophageal cancer

          2. Patients > or = 18 years old

          3. Patients who will receive chemotherapy and radiation therapy

          4. Patients who speak English or Spanish

          5. Patients must be willing and able to review, understand, and provide written consent
             before starting therapy

          6. Patients must agree to discontinue St John's Wort herbal supplement use, and refrain
             from taking it while on protocol

          7. Women of childbearing potential (women who are not postmenopausal for at least 1 year
             and are not surgically sterile) must have a negative urine pregnancy test

          8. Sexually active males and females must agree to use effective birth control or to be
             abstinent for the duration of the study period

          9. Women currently taking birth control pills or planning to start birth control pills
             must agree to an additional method of birth control (either abstinence or a barrier
             method) while on the study medication and for 1 additional month after study
             completion.

        Exclusion Criteria:

          1. Patients who are enrolled in other symptom management clinical trials

          2. Patients currently taking methylphenidate and/or dextroamphetamine

          3. Patients with a history of clinically significant cutaneous drug reaction, or a
             history of clinically significant hypersensitivity reaction, as documented in the
             patient medical records

          4. Patients with pre-existing psychosis or bipolar disorder

          5. Patients with pre-existing renal impairment: The screening cut off for serum
             creatinine >1.5 times the upper limit of normal, within the past 30 days, will be done
             by the oncologist to qualify for CXRT.

          6. Patients with pre-existing hepatic impairment: The screening for total bilirubin >25.7
             µmol/L (1.5 mg/dL) will be done by the oncologist to qualify for CXRT. The screening
             for > 2 times the upper limit of normal hepatotoxicity, alkaline phosphatase (ALP),
             and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) will be done by
             the oncologist to qualify for CXRT.

          7. Patients with pre-existing Tourette's syndrome

          8. Patients with hypersensitivity to any tetracyclines

          9. Patients with uncontrolled cardiac disease, including angina and cardiac ischemia,
             left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.

         10. Patients taking medicines that are strong CYP3A4 inhibitors or inducers (including
             conivaptan, indinavir, nelfinavir, ritonavir, nefazodone, and phenetoin), or strong
             CYP2C19 inhibitors (including citalopram and clopidogrel).

         11. Patients on vitamin K antagonist warfarin