A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Combined AUC for Selected Symptoms
研究概览
简要总结
The goal of this clinical research study is to compare armodafinil, bupropion, curcumin, 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:
It is not known which study drug or combination of study drugs is better at reducing side effects patients may experience during chemoradiation therapy. For this reason, researchers have chosen 4 study drugs that may help to reduce side effects. The study drugs will be tested alone and in combination with each other.
Armodafinil is designed to prevent excessive sleepiness.
Bupropion is an antidepressant with anti-inflammatory properties that may help reduce multiple symptoms.
Curcumin is the active ingredient in the spice, turmeric. It may interfere with the production of cytokines (which cause inflammation), which may reduce multiple symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（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 unresectable Non-small-cell lung carcinoma (NSCLC) and consented to concurrent chemoradiation therapy in MD Anderson Cancer Center (MDACC).
- •Patients >= 18 years old and <= 65 years old
- •Patients who will receive chemoradiation with platinum/taxane based chemo and with a total radiation dose of > or = 50 Gy, per treating physician's assessment
- •Patients who speak English only (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol)
- •Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol
- •Patients must be willing and able to review, understand, and provide written consent before starting therapy
- •Patients already taking any of this trial's symptom treatment medications (including modafinil) must be willing to stop taking the medication/s for a washout period of 30 days before they are randomized to a symptom treatment arm and begin the symptom trial
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 taking CHANTIX (smoking cessation medication)
- •Patients who are enrolled in other symptom management or treatment clinical trials
- •Bile duct obstruction or cholelithiasis
- •History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction
- •Pre-existing psychosis or bipolar disorder
- •Pre-existing renal impairment: The screening cut off for serum creatinine >1.5mg/dl will be done by the oncologist to qualify for CXRT.
- •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 chemoradiation treatment (CXRT). The screening for 2 times the upper limit of normal Hepatotoxicity (Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT) will be done by the oncologist to qualify for CXRT.
- •Pre-existing Tourette's syndrome
- •Seizure disorder
- •Anorexia/bulimia in past two months
- •Use of monoamine oxidase (MAO) inhibitors within 14 days
- •Patients undergoing abrupt discontinuation of ethanol or sedatives (including benzodiazepines)
- •Patients receiving other dosage forms of bupropion if they do not agree to undergo a washout period
- •Allergy to turmeric or any of its constituents, including curcumin, to yellow food coloring, or to member of the Zingiberaceae (ginger) family
- •Gastric or duodenal ulcers, or gastric hyperacidity disorders
- •Hypersensitivity to any tetracyclines
- •Patients to be confirmed as not pregnant (serum HCG negative). The screening for this will be done by the oncologist in qualifying for CXRT.
- •Patients with a history of cardiac disease, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.
- •Patients taking antifungals, antiretrovirals, and macrolides that are strong CYP3A4 strong inhibitors including indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, and nefazodone.
- •Patients on anticoagulants (ie warfarin/heparin)
- •Patients with International Normalized Ratio (INR) > 1.5.
研究组 & 干预措施
Questionnaires and Phone Calls
Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
干预措施: Telephone Questionnaire (Behavioral)
Curcumin Only
干预措施: Curcumin (Drug)
Curcumin Only
干预措施: Telephone Questionnaire (Behavioral)
Armodafinil Only
干预措施: Armodafinil (Drug)
Armodafinil Only
干预措施: Telephone Questionnaire (Behavioral)
Minocycline Only
干预措施: Minocycline (Drug)
Minocycline Only
干预措施: Telephone Questionnaire (Behavioral)
Bupropion Only
干预措施: Bupropion (Drug)
Curcumin + Minocycline
干预措施: Minocycline (Drug)
Bupropion Only
干预措施: Telephone Questionnaire (Behavioral)
Curcumin + Armodafinil
干预措施: Armodafinil (Drug)
Curcumin + Armodafinil
干预措施: Curcumin (Drug)
Curcumin + Armodafinil
干预措施: Telephone Questionnaire (Behavioral)
Curcumin + Minocycline
干预措施: Curcumin (Drug)
Curcumin + Minocycline
干预措施: Telephone Questionnaire (Behavioral)
Curcumin + Bupropion
干预措施: Bupropion (Drug)
Curcumin + Bupropion
干预措施: Curcumin (Drug)
Curcumin + Bupropion
干预措施: Telephone Questionnaire (Behavioral)
Armodafinil + Minocycline
干预措施: Armodafinil (Drug)
Armodafinil + Minocycline
干预措施: Minocycline (Drug)
Armodafinil + Minocycline
干预措施: Telephone Questionnaire (Behavioral)
Armodafinil + Bupropion
干预措施: Armodafinil (Drug)
Armodafinil + Bupropion
干预措施: Bupropion (Drug)
Armodafinil + Bupropion
干预措施: Telephone Questionnaire (Behavioral)
Minocycline + Buproprion
干预措施: Bupropion (Drug)
Minocycline + Buproprion
干预措施: Minocycline (Drug)
Minocycline + Buproprion
干预措施: Telephone Questionnaire (Behavioral)
Curcumin + Armodafinil + Minocycline
干预措施: Armodafinil (Drug)
Curcumin + Armodafinil + Minocycline
干预措施: Minocycline (Drug)
Curcumin + Armodafinil + Minocycline
干预措施: Curcumin (Drug)
Curcumin + Armodafinil + Minocycline
干预措施: Telephone Questionnaire (Behavioral)
Curcumin + Armodafinil + Bupropion
干预措施: Armodafinil (Drug)
Curcumin + Armodafinil + Bupropion
干预措施: Bupropion (Drug)
Curcumin + Armodafinil + Bupropion
干预措施: Curcumin (Drug)
Curcumin + Armodafinil + Bupropion
干预措施: Telephone Questionnaire (Behavioral)
Curcumin + Minocycline + Bupropion
干预措施: Bupropion (Drug)
Curcumin + Minocycline + Bupropion
干预措施: Minocycline (Drug)
Curcumin + Minocycline + Bupropion
干预措施: Curcumin (Drug)
Curcumin + Minocycline + Bupropion
干预措施: Telephone Questionnaire (Behavioral)
Armodafinil + Minocycline + Bupropion
干预措施: Armodafinil (Drug)
Armodafinil + Minocycline + Bupropion
干预措施: Bupropion (Drug)
Armodafinil + Minocycline + Bupropion
干预措施: Minocycline (Drug)
Armodafinil + Minocycline + Bupropion
干预措施: Telephone Questionnaire (Behavioral)
Curcumin + Armodafinil + Minocycline + Bupropion
干预措施: Armodafinil (Drug)
Curcumin + Armodafinil + Minocycline + Bupropion
干预措施: Bupropion (Drug)
Curcumin + Armodafinil + Minocycline + Bupropion
干预措施: Minocycline (Drug)
Curcumin + Armodafinil + Minocycline + Bupropion
干预措施: Curcumin (Drug)
Curcumin + Armodafinil + Minocycline + Bupropion
干预措施: Telephone Questionnaire (Behavioral)
结局指标
主要结局
Combined AUC for Selected Symptoms
时间窗: 10-weeks (+/- 4 days)
次要结局
未报告次要终点