Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.
|ClinicalTrials.gov Identifier: NCT01173692|
Recruitment Status : Active, not recruiting
First Posted : August 2, 2010
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Oropharynx Cancer||Drug: Minocycline Drug: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 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 2010|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
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.
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|