A Pilot Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness
研究概览
简要总结
The goal of this clinical research study is to compare armodafinil and minocycline when given alone or in combination to learn which is better for controlling symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.
详细描述
The Study Drugs:
Armodafinil is designed to prevent excessive sleepiness.
Minocycline is an antibiotic. Minocycline has been shown to interrupt cytokine production, which may help to reduce multiple symptoms.
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.
Study Groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, 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 concurrent chemoradiation therapy at MD Anderson.
- •Patients > or =18 years old
- •Patients who will receive chemoradiation with platinum/taxane-based chemotherapy and with a total radiation dose of > 50 Gy, per treating physician's assessment
- •Patients who speak English or Spanish (due to the novel research and its complexity, we are only accruing English or Spanish-speaking patients to the protocol)
- •Patients must be willing and able to review, understand, and provide written consent before starting therapy
排除标准
- •Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions, as determined by the treating physician
- •Patients who are enrolled in other symptom management or treatment clinical trials
- •Patients currently taking methylphenidate and/or dextroamphetamine.
- •Patients with a history of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction as documented in the patient medical records
- •Patients with pre-existing psychosis or bipolar disorder.
- •Patients with pre-existing renal impairment: The screening cut off for serum creatinine >1.5 times upper limits of normal (ULN), according to MD Anderson testing standards, will be done by the oncologist to qualify for CXRT.
- •Patients with pre-existing hepatic impairment: The screening for total bilirubin >1.5 times ULN will be done by the oncologist to qualify for CXRT. The screening for > 2 times the upper limit of normal hepatotoxicity, alkaline phosphatase (ALP) and alanine aminotransferase (ALT) (and aspartate aminotransferase [AST] if it is ordered and available in the medical records) will be done by the oncologist to qualify for CXRT.
- •Patients with pre-existing Tourette's syndrome.
- •Patients with hypersensitivity to any tetracyclines.
- •Patients who are pregnant. Pregnancy will be confirmed by negative urine test. Study staff will provide the pregnancy kits to women and make sure the results are known and recorded in the follow-up notes in Clinic Station before additional study drug prescriptions are filled by the Pharmacy
- •Patients with uncontrolled cardiac disease, within the past six months history of left ventricular hypertrophy, myocardial infarction, and history of mitral valve prolapse syndrome with previous central nervous system (CNS) stimulant use.
- •Patients taking medicines that are strong CYP3A4 inhibitors or inducers (including conivaptan, indinavir, nelfinavir, ritonavir, nefazodone, and phenytoin), or strong CYP2C19 inhibitors (including citalopram and clopidogrel) .
- •Patients on vitamin K antagonist warfarin.
研究组 & 干预措施
Armodafinil + Placebo
Armodafinil orally 150 mg/day + Placebo capsules for 10 weeks
干预措施: Armodafinil (Drug)
Armodafinil + Placebo
Armodafinil orally 150 mg/day + Placebo capsules for 10 weeks
干预措施: Placebo (Other)
Armodafinil + Placebo
Armodafinil orally 150 mg/day + Placebo capsules for 10 weeks
干预措施: Questionnaires (Behavioral)
Minocycline + Placebo
Minocycline orally 100 mg twice/day + Placebo capsules for 10 weeks
干预措施: Placebo (Other)
Minocycline + Placebo
Minocycline orally 100 mg twice/day + Placebo capsules for 10 weeks
干预措施: Minocycline (Drug)
Minocycline + Placebo
Minocycline orally 100 mg twice/day + Placebo capsules for 10 weeks
干预措施: Questionnaires (Behavioral)
Armodafinil + Minocycline
Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks
干预措施: Armodafinil (Drug)
Armodafinil + Minocycline
Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks
干预措施: Minocycline (Drug)
Armodafinil + Minocycline
Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks
干预措施: Questionnaires (Behavioral)
Placebos
Placebo Capsules orally once/day for 10 weeks
干预措施: Placebo (Other)
Placebos
Placebo Capsules orally once/day for 10 weeks
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness
时间窗: During 10 weeks of CXRT
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 using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0\*70) to 700 (10\*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.
次要结局
未报告次要终点