A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Head and Neck Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Treatment Effects on 5 Selected Symptoms (Average MDASI-HNC Scores)
研究概览
简要总结
The goal of this clinical research study is to compare armodafinil, bupropion, and minocycline when given alone or in combination. Researchers want to learn about the safety and level of effectiveness of these drugs in controlling symptoms, such as the side effects of chemoradiation, when given to patients with head and neck 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 3 study drugs that may help to reduce side effects such as fatigue, pain, sleep disturbance, difficulty swallowing, and lack of appetite. The study drugs will be tested alone and in combination with each other.
- Armodafinil is designed to prevent excessive sleepiness.
- Bupropion and minocycline each may reduce inflammation, which may help to reduce other symptoms. Bupropion is a drug for depression. Minocycline is an antibiotic (a drug to treat infection).
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 8 groups. You may be assigned to receive no study drugs, 1 study drug, a combination of 2, or all 3 of the study drugs.
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 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 epithelial carcinoma of the oropharynx, nasopharynx, hypopharynx, larynx, or oral cavity being treated at MDACC.
- •Patients >/= 18 years old and </= 65 years old.
- •Patients with the above cancers scheduled to receive definitive concurrent chemoradiation over 6 - 7 weeks.
- •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, understand, and provide written consent.
- •Women of childbearing potential (women who are not postmenopausal for at least one year and are not surgically sterile) must have negative urine pregnancy test..
- •Sexually active males and females must agree to use birth control or abstinence for the duration of the 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 trial or receiving active therapy as part of a treatment clinical trial.
- •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. Patients with major depressive disorder or severe depression (a score of 13 or greater on the BDI Fast Screen (BDI-FS) will be excluded. If this is the case, we will notify their treating physician for appropriate management or referral.
- •Pre-existing renal impairment: The screening cut off for serum creatinine > the upper limit of normal, will be done by the oncologist to qualify for chemoradiation.
- •Pre-existing hepatic impairment: The screening for total bilirubin > 1.5 times the upper limit of normal will be done by the oncologist to qualify for chemoradiation. The screening for >2 times the upper limit of normal hepatotoxicity: Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT) will be done by the oncologist to qualify for chemoradiation.The screening results for Aspartate aminotransferase (AST) must be < 2 times the upper limit of normal if available in the medical records.
- •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 currently taking any of the study drugs
- •Hypersensitivity to any tetracyclines
- •Patients on anticoagulants (ie warfarin/heparin)
- •Patients with INR > 1.
- •Patients being treated with concurrent cetuximab chemotherapy with radiation therapy.
- •Patients currently receiving any tetracycline family antibiotic or within the previous past 14 days before chemoradiation.
- •Previous radiation therapy for a cancer in the head and neck region.
- •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.
研究组 & 干预措施
Placebo
Placebo by mouth 2 times every day.
干预措施: Placebo (Other)
Armodafinil
Armodafinil 150 mg by mouth once a day.
干预措施: Armodafinil (Drug)
Minocycline
Minocycline 100 mg by muth two times a day.
干预措施: Minocycline (Drug)
Bupropion
Bupropion 100 mg by mouth two times a day.
干预措施: Bupropion (Drug)
Armodafinil + Minocycline
Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by mouth two times a day.
干预措施: Armodafinil (Drug)
Armodafinil + Minocycline
Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by mouth two times a day.
干预措施: Minocycline (Drug)
Armodafinil + Bupropion
Armodafinil 150 mg by mouth once a day.
Bupropion 100 mg by mouth two times a day.
干预措施: Armodafinil (Drug)
Armodafinil + Bupropion
Armodafinil 150 mg by mouth once a day.
Bupropion 100 mg by mouth two times a day.
干预措施: Bupropion (Drug)
Minocycline + Bupropion
Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day.
干预措施: Minocycline (Drug)
Minocycline + Bupropion
Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day.
干预措施: Bupropion (Drug)
Armodafinil + Minocycline + Bupropion
Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day.
干预措施: Armodafinil (Drug)
Armodafinil + Minocycline + Bupropion
Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day.
干预措施: Minocycline (Drug)
Armodafinil + Minocycline + Bupropion
Armodafinil 150 mg by mouth once a day.
Minocycline 100 mg by muth two times a day.
Bupropion 100 mg by mouth two times a day.
干预措施: Bupropion (Drug)
结局指标
主要结局
Treatment Effects on 5 Selected Symptoms (Average MDASI-HNC Scores)
时间窗: 10 weeks
Treatments ability to reduce values of 5 symptoms comprised of MD Anderson Symptom Inventory (MDASI)-Head and Neck Cancer (HNC) scores for fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite collected during the 10 weeks of chemoradiation treatment. symptoms that are caused by their disease or by their treatment. Symptom severity score is comprised of average of the five above MDASI core items (fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.
次要结局
未报告次要终点