Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01173692|
Recruitment Status : Completed
First Posted : August 2, 2010
Last Update Posted : July 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Oropharynx Cancer||Drug: Minocycline Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.|
|Actual Study Start Date :||July 22, 2010|
|Actual Primary Completion Date :||July 3, 2020|
|Actual Study Completion Date :||July 3, 2020|
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.
- 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|