Esophageal Cancer Clinical Trial
Official title:
A Randomized Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer
Verified date | May 2018 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks. | Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores | Baseline, 6 weeks |
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