A Randomized, Placebo Controlled-Double Blind Study of Minocycline for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer
If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to 1 of 2 groups. Group 1 will take minocycline. Group 2 will take a placebo.
Neither you nor the study staff will know if you are receiving the study drug or the
placebo. However, if needed for your safety, the study staff will be able to find out what
you are receiving.
Study Drug Administration:
You will take the study drug/placebo by mouth, every day for 7 weeks, starting on the first
week of chemoradiation therapy.
You may take the study drug/placebo with a full glass (8 ounces) of water. You may take it
with or without food, but if it causes an upset stomach, you should take it with food.
If you have trouble swallowing the dose of study drug/placebo, you can open the capsule
right before you take it. You should not lie down for at least 30 minutes after taking the
study drug/placebo to reduce the risk of side effects.
You must bring the study drug/placebo container (along with any remaining drug) to every
Before you start your chemoradiation treatment:
-You will fill out 4 questionnaires about pain and other symptoms, your tobacco history,
your health status, and your quality of life. It should take about 15 minutes to complete
all of the questionnaires.
During chemoradiation treatment (about Weeks 1-7 of chemoradiation):
- You will complete the symptom questionnaire in the clinic or by telephone 1 time each
week. The symptom questionnaire should take about 5 minutes to complete each time.
- Each week you will be asked about any symptoms you may be having and how they may be
affecting your daily activities.
At about Week 4 of chemoradiation:
-You will complete 3 questionnaires about pain and other symptoms, your health status, and
your quality of life. It should take about 10 minutes to complete all of the questionnaires.
During the last week of chemoradiation (about Week 6-7):
-You will complete 4 questionnaires about pain and other symptoms, your health status, your
quality of life, and your satisfaction with the study drug/placebo. It should take about 15
minutes to complete all of the questionnaires.
After the last week of chemoradiation (about Weeks 7-12):
-The study staff will call you 1 time each week to check on you and to complete the pain and
symptoms questionnaire at a time that is convenient for you. This phone call should last
about 10 minutes. If you have had several side effects from the chemoradiation therapy,
this phone call may take longer.
End of Study Visit:
Your last study visit will be the same day that you have your last clinic visit with the
chemoradiation doctor (around Weeks 12-13). At this visit, you will complete the pain and
other symptoms questionnaire, the health status questionnaire, and the smoking
questionnaires. It should take about 10 minutes to complete all questionnaires.
Length of Study:
You will be on study for up to 13 weeks. You will take the study drug/placebo for up to 7
weeks and continue to complete the questionnaires until 12-13 weeks. You will be taken off
study early if you have intolerable side effects or the study doctor thinks it is in your
This is an investigational study. Minocycline is FDA approved and commercially available
for the treatment of bacterial infection. Using minocycline to treat side effects of
chemoradiation treatment in patients with NSCLC is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
AUC Value Symptom Severity Differences
Primary outcome variable for this trial will be the mean difference between AUC values recorded for patients assigned to the treatment and control arms. AUC values calculated for the five M.D. Anderson Symptom Inventory (MDASI) items corresponding to fatigue, pain, disturbed sleep, lack of appetite, and sore throat. AUC is sum of the area of the trapezoids that can be fitted during the 12 week period and is measured in units of mean MDASI score in days.
Zhongxing Liao, MD
UT MD Anderson Cancer Center
United States: Federal Government
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