Phase 2
Completed N=19
A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer
Source: ClinicalTrials.gov NCT01746043 ↗Enrolled (actual)
19
Serious AEs
21.1%
Results posted
Jun 2018
Primary outcomePrimary: Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks. — 0; 2; 1; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks. |
0; 2; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with a pathologically proven diagnosis of esophageal cancer
- Patients > or = 18 years old
- Patients who will receive chemotherapy and radiation therapy
- Patients who speak English or Spanish
- Patients must be willing and able to review, understand, and provide written consent before starting therapy
- Patients must agree to discontinue St John's Wort herbal supplement use, and refrain from taking it while on protocol
- 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
- Sexually active males and females must agree to use effective birth control or to be abstinent for the duration of the study period
- 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
- Patients who are enrolled in other symptom management clinical trials
- Patients currently taking methylphenidate and/or dextroamphetamine
- 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
- Patients with pre-existing psychosis or bipolar disorder
- 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.
- 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.
- Patients with pre-existing Tourette's syndrome
- Patients with hypersensitivity to any tetracyclines
- Patients with uncontrolled cardiac disease, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.
- 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).
- Patients on vitamin K antagonist warfarin
Data sourced from ClinicalTrials.gov (NCT01746043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.