A Randomized, Placebo Controlled-Double Blind Study of Minocycline for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- AUC Value Symptom Severity Differences
研究概览
简要总结
The goal of this clinical research study is to learn if minocycline can reduce the side effects reported by patients with NSCLC who are receiving chemoradiation therapy. In this study, minocycline will be compared to a placebo.
Minocycline is an antibiotic that may help to reduce side effects of chemoradiation therapy.
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.
详细描述
Study Groups:
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 during chemoradiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a pathologically proven diagnosis of NSCLC and consented to receive CXRT at MD Anderson
- •Patients > or = 18 years old
- •Patients who will receive CXRT with platinum/taxane-based chemotherapy and with a total radiation dose of >or = 50 Gy, per treating physician's assessment
- •Patients who speak English or Spanish (due to MDASI language options, we are only accruing English-speaking or Spanish-speaking patients to the protocol)
- •Patients willing and able to review, understand, and provide written consent before starting therapy
- •Patients with normal renal function according to MD Anderson testing standards and no prior renal disease [screening cut off for serum creatinine < 1.5 times ULN]
- •Patients must have the following screening results for hepatic function according to MD Anderson testing standards: total bilirubin < 1.5 times the upper limit of normal; alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST - if available) must be < 2 times the upper limit of normal
排除标准
- •Patients with a history of clinically significant cutaneous drug reaction to minocycline, as documented in the patient medical records
- •Patients who are enrolled in other symptom management or symptom clinical trials
- •Patients who currently have bile duct obstruction or cholelithiasis
- •Patients with hypersensitivity to any tetracyclines
- •Patients who are pregnant; pregnancy will be confirmed by negative urine test
- •Patients on vitamin K antagonist warfarin
研究组 & 干预措施
Minocycline
Two-arm, placebo-controlled pilot study to obtain preliminary estimates of treatment effects of minocycline in patients with non small cell lung cancer (NSCLC) being consented for concurrent chemoradiation (CXRT). Minocycline 100 mg capsules taken by mouth two times a day every day for 7 weeks, starting on the first week of chemoradiation therapy. Questionnaires at baseline, timepoints during chemoradiation, and at treatment completion for 12 weeks.
干预措施: Minocycline (Drug)
Minocycline
Two-arm, placebo-controlled pilot study to obtain preliminary estimates of treatment effects of minocycline in patients with non small cell lung cancer (NSCLC) being consented for concurrent chemoradiation (CXRT). Minocycline 100 mg capsules taken by mouth two times a day every day for 7 weeks, starting on the first week of chemoradiation therapy. Questionnaires at baseline, timepoints during chemoradiation, and at treatment completion for 12 weeks.
干预措施: Questionnaires (Behavioral)
Placebo
Two-arm, placebo-controlled pilot study to obtain preliminary estimates of treatment effects of minocycline in patients with non small cell lung cancer (NSCLC) being consented for concurrent chemoradiation (CXRT). Placebo capsules taken by mouth two times a day every day for 7 weeks, starting on the first week of chemoradiation therapy. Questionnaires at baseline, timepoints during chemoradiation, and at treatment completion for 12 weeks.
干预措施: Placebo (Other)
Placebo
Two-arm, placebo-controlled pilot study to obtain preliminary estimates of treatment effects of minocycline in patients with non small cell lung cancer (NSCLC) being consented for concurrent chemoradiation (CXRT). Placebo capsules taken by mouth two times a day every day for 7 weeks, starting on the first week of chemoradiation therapy. Questionnaires at baseline, timepoints during chemoradiation, and at treatment completion for 12 weeks.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
AUC Value Symptom Severity Differences
时间窗: up to 12 weeks
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. Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference.
次要结局
- Number of Participants With Treatment-Induced Inflammatory Response(up to 12 weeks)