Minocycline in Oropharynx Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.|
- Combined AUC for Selected Patient Symptoms [ Time Frame: 7 weeks. They will take the study drug/placebo for up to 7 weeks and continue to complete the symptom survey until 15 weeks. ] [ Designated as safety issue: No ]7-week (+/- 5 days) area under the curve (AUC) for select MDASI-HNC symptoms namely fatigue, pain, sleep disturbance, difficulty swallowing and lack of appetite reported in the symptom survey.
|Study Start Date:||July 2010|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Twice Daily Orally
Twice daily by mouth, every day for 7 weeks starting at first day of radiation therapy.
Other Name: Sugar Pill
100 mg Twice Daily Orally
100 mg twice daily (200 mg) by mouth , every day for 7 weeks starting first day of radiation therapy.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01173692
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gary B. Gunn, MD||M.D. Anderson Cancer Center|