A Randomized Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.
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 side effects of chemoradiation treatment for esophageal cancer (such as fatigue, pain, disturbed sleep, lack of appetite, and drowsiness).
Armodafinil is designed to prevent excessive sleepiness.
Minocycline is an antibiotic, which may help to reduce multiple symptoms.
In this study, you may receive a placebo. 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 are eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to join 1 of 4 groups. You will have an equal chance of being in any group.
- Group 1 will take armodafinil and a placebo.
- Group 2 will take minocycline and a placebo.
- Group 3 will take armodafinil and minocycline.
- Group 4 will take 2 placebos.
Neither you nor the study staff you will see in the clinic will know if you are receiving the study drug(s) and/or the placebo(s). However, if needed for your safety, the study staff will be able to find out which study drug you are receiving.
If needed, you will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
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 esophageal cancer
- •Patients > or = 18 years old
- •Patients who will receive chemotherapy and radiation therapy
- •Patients who speak English or Spanish
- •Patients must be willing and able to review, understand, and provide written consent before starting therapy
- •Patients must agree to discontinue St John's Wort herbal supplement use, and refrain from taking it while on protocol
- •Women of childbearing potential (women who are not postmenopausal for at least 1 year and are not surgically sterile) must have a negative urine pregnancy test
- •Sexually active males and females must agree to use effective birth control or to be abstinent for the duration of the study period
- •Women currently taking birth control pills or planning to start birth control pills must agree to an additional method of birth control (either abstinence or a barrier method) while on the study medication and for 1 additional month after study completion.
排除标准
- •Patients who are enrolled in other symptom management 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, 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 the upper limit of normal, within the past 30 days, will be done by the oncologist to qualify for CXRT.
- •Patients with pre-existing hepatic impairment: The screening for total bilirubin >25.7 µmol/L (1.5 mg/dL) 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) or aspartate aminotransferase (AST) will be done by the oncologist to qualify for CXRT.
- •Patients with pre-existing Tourette's syndrome
- •Patients with hypersensitivity to any tetracyclines
- •Patients with uncontrolled cardiac disease, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.
- •Patients taking medicines that are strong CYP3A4 inhibitors or inducers (including conivaptan, indinavir, nelfinavir, ritonavir, nefazodone, and phenetoin), or strong CYP2C19 inhibitors (including citalopram and clopidogrel).
- •Patients on vitamin K antagonist warfarin
研究组 & 干预措施
Armodafinil + Placebo
Armodafinil 150 mg by mouth once a day for 6 weeks. Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.
干预措施: Armodafinil (Drug)
Armodafinil + Placebo
Armodafinil 150 mg by mouth once a day for 6 weeks. Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.
干预措施: Placebo (Other)
Armodafinil + Placebo
Armodafinil 150 mg by mouth once a day for 6 weeks. Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.
干预措施: Questionnaires (Behavioral)
Minocycline + Placebo
Minocycline 100 mg by mouth 2 times a day for 6 weeks. Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.
干预措施: Placebo (Other)
Minocycline + Placebo
Minocycline 100 mg by mouth 2 times a day for 6 weeks. Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.
干预措施: Minocycline (Drug)
Minocycline + Placebo
Minocycline 100 mg by mouth 2 times a day for 6 weeks. Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.
干预措施: Questionnaires (Behavioral)
Armodafinil + Minocycline
Armodafinil 150 mg by mouth once a day for 6 weeks. Minocycline 100 mg by mouth 2 times a day for 6 weeks.Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.
干预措施: Armodafinil (Drug)
Armodafinil + Minocycline
Armodafinil 150 mg by mouth once a day for 6 weeks. Minocycline 100 mg by mouth 2 times a day for 6 weeks.Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.
干预措施: Minocycline (Drug)
Armodafinil + Minocycline
Armodafinil 150 mg by mouth once a day for 6 weeks. Minocycline 100 mg by mouth 2 times a day for 6 weeks.Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.
干预措施: Questionnaires (Behavioral)
Placebos
Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.
干预措施: Placebo (Other)
Placebos
Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.
时间窗: Baseline, 6 weeks
Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores
次要结局
未报告次要终点