Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Combined AUC for Selected Patient Symptoms
研究概览
简要总结
The goal of this clinical research study is to learn if minocycline can reduce the symptoms reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer of head and neck, who receive treatment with radiation therapy.
详细描述
The Study Drug:
Minocycline is an antibiotic and has been shown to interrupt cytokine production, which may help to reduce multiple symptoms.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take minocycline. Group 2 will take a placebo. A placebo is a substance that looks like the study drug but has no active ingredients.
Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 oropharyngeal cancer, nasopharyngeal cancer, or unknown primary cancer of head and neck in MDACC receiving radiation therapy with or without induction chemotherapy.
- •Patients > = 18 years old.
- •Patients with the above cancers, T0, TX, T1 to T3, N any, M0 receiving IMRT (to unilateral or bilateral neck) at least 64-72 Gy in 6-7 weeks as definitive treatment.
- •Patients must have normal renal function test and no prior renal disease: The screening cut off for serum creatinine < upper limit of normal.
- •Patients must have normal hepatic function test and no prior liver disease: The screening results for total bilirubin must be < 1.5 times the upper limit of normal. The screening results for the following must be < 2 times the upper limit of normal for patients to be eligible: Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT). The screening results for Aspartate aminotransferase (AST) must be < 2 times the upper limit of normal if available.
- •Patients who speak English (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol).
- •Patients must be willing to discontinue taking dong quai and/or St John's wort.
- •Patients must be willing and able to review, understand, and provide written consent.
排除标准
- •Patients receiving concurrent chemotherapy or concurrent biologic agent.
- •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 another symptom management trial or receiving active treatment under another 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.
- •Hypersensitivity to any tetracyclines.
- •Patients on anticoagulants (ie warfarin/heparin).
- •Patients with INR > 1.
- •Patients taking any tetracycline within the last 15 days.
- •Patients that are pregnant.
- •Patients treated with upfront radical surgery at the primary site (other than diagnostic tonsillectomy or excision).
研究组 & 干预措施
Placebo
Twice Daily Orally
干预措施: Placebo (Drug)
Minocycline
100 mg Twice Daily Orally
干预措施: Minocycline (Drug)
结局指标
主要结局
Combined AUC for Selected Patient Symptoms
时间窗: Up to 7 weeks
7-week (+/- 5 days) average area under the curve (AUC) for select MD Anderson Symptom Inventory for head and neck cancer (MDASI-HNC) symptoms namely fatigue, pain, sleep disturbance, difficulty swallowing and lack of appetite reported in the symptom survey. Each item is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine). Higher values represent a worse outcome.
次要结局
未报告次要终点