Armodafinil for Persistent Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer: a Randomized Phase II Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Brief Fatigue Inventory-Worst
研究概览
简要总结
The goal of this clinical research study is to learn if armodafinil can reduce fatigue and other common symptoms in patients that have received treatment for head and neck cancer.
详细描述
Armodafinil is designed to stimulate the central nervous system, which may increase wakefulness and reduce fatigue.
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:
If participant is found eligible to take part in this study, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take armodafinil. Group 2 will take a placebo. A placebo is a substance that looks like the study drug but has no active ingredients.
Neither participant nor the study staff will know if participant is receiving the study drug or the placebo. However, if needed for participant's safety, the study staff will be able to find out what participant is receiving.
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
- 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 who were treated with either definitive or postoperative radiation or chemoradiation therapy for HNC with moderate to severe levels of patient reported fatigue, at 6 or more weeks after completing all planned cancer therapy. Patients who rated their fatigue level at 5 or greater on a 0 to 10 scale during any follow-up clinic visits at MD Anderson.
- •Male and female patients >= 18 years old.
- •Patients who speak English (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 and understand informed consent documents and to provide written consent.
- •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 rated their fatigue level at 4 or less over the past 24 hours based on the fatigue at its worst item of the BFI.
- •Patients with clinical evidence of active persistent cancer or progressive disease after completing planned cancer therapy, or with active recurrent cancer.
- •Patients with potential medical or other underlying causes of fatigue, as determined by the treating physician or PI
- •Patients with Hb <10.5 g/dL within previous 2 weeks.
- •Patients with untreated or uncontrolled hypothyroidism, or TSH > ULN or free T4 < lower level of normal within previous 2 weeks.
- •Patients with underlying cardiac or pulmonary disease resulting in dyspnea, hypoxia, or hypercapnia.
- •Patients with a Karnofsky performance status <70
- •Patients less than 18 years old
- •Patients who are enrolled and receiving active treatment in other symptom intervention trials or who are in the treatment phase of another clinical trial
- •Patients with pre-existing psychosis or bipolar disorder
- •Patients with pre-existing renal impairment, as evidenced by serum creatinine > ULN on the most recent blood work, done at least within the previous 2 weeks.
- •Patients with pre-existing cirrhosis or hepatic impairment or with abnormal liver function test as evidenced by total bilirubin > 1.5 x ULN or 2 times the upper limit of normal of alkaline phosphatase (ALP), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) on the most recent blood work, done at least within the previous 2 weeks.
- •Patients with pre-existing Tourette's syndrome
- •Patients who have used monoamine oxidase (MAO inhibitors) within the past 14 days
- •Patients undergoing abrupt discontinuation of ethanol or sedatives (including benzodiazepines)
- •Patients currently taking, or having taken within the previous 1 month, armodafinil, modafinil, amphetamine, or methylphenidate
- •Patients on anticoagulants (i.e. warfarin, coumadin, or heparin) or clopidogrel
- •Patients with a history of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions
- •Patients with a history of angina or cardiac ischemia, a recent history of myocardial infarction (within the past 1 year) or left ventricular hypertrophy, or patients with mitral valve prolapse
- •Patients with uncontrolled hypertension or tachycardia, as determined by treating physician
- •Patients who are pregnant, breastfeeding, or planning to become pregnant during the study period and for 1 month after stopping the study drug.
- •Female patients who are currently on birth control pills as primary means of contraception, but are not willing to seek an additional effective method of contraception (such as barrier method) during the study period and for 1 month after stopping the study drug.
- •Patients with a history of CNS stimulant abuse, such as methylphenidate, dextroamphetamine, or modafinil.
- •Patients with major depressive disorder or severe depression (a score of 13 or greater on the BDI Fast Screen (BDI-FS). If this is the case, we will notify their treating physician for appropriate management or referral.
- •Patients with current or a history of suicidal ideation.
- •Patients currently taking midazolam, cyclosporine, ethinyl estradiol, or triazolam
- •Patients currently taking carbamazepine, phenobarbital, rifampin, aminoglutethimide, nafcillin, nevirapine, phenytoin, azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, telithromycin, or verapamil
- •Patients currently taking omeprazole, diazepam, propanolol, chlomipramine (or other tricyclic antidepressants), citalopram, methsuximide, or sertraline.
研究组 & 干预措施
Armodafinil
50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period.
干预措施: Armodafinil (Drug)
Armodafinil
50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period.
干预措施: Questionnaires (Behavioral)
Placebo
1 Placebo by mouth every morning for a 28 day cycle.
干预措施: Placebo (Other)
Placebo
1 Placebo by mouth every morning for a 28 day cycle.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Brief Fatigue Inventory-Worst
时间窗: 4-6 weeks
The primary outcome measure is item 3 on the Brief Fatigue Inventory (BFI) scale: "Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your WORST level of fatigue during past 24 hours." The item is on a 10-point Likert scale from 0 (no fatigue) to 10 (as bad as you can imagine). Thus, higher values represent worse outcomes. The primary outcome measure is the area under the curve (AUC), using the trapezoidal rule, for the BFI-Worst Fatigue scores over 28 days. The range for BFI-Worst Fatigue AUC is from 0 to 280.
次要结局
未报告次要终点