Minocycline for Reduction of Symptom Burden After Surgery in Patients With Head and Neck Malignancy: A Randomized Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy of Minocycline for Reducing Patient-Reported Symptoms
研究概览
简要总结
The goal of this clinical research study is to learn if Minocin® (minocycline) can reduce certain side effects of surgery in patients with head and neck cancer (such as pain, fatigue, and disturbed sleep). In this study, minocycline will be compared to a placebo.
A placebo is not a drug. It looks like the study drug, but it 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 found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being in any group.
- If you are in Group 1, you will receive minocycline.
- If you are in Group 2, you will receive a placebo.
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.
Study Drug Administration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 head and neck cancer who are undergoing either flap or nonflap surgery (limited to parotidectomy, hard palate maxillectomy and glossectomy, mandibulectomy, and any procedure with neck dissection) at MD Anderson Cancer Center.
- •Patients > 18 years old.
- •Patients who have not undergone surgery in the past 6 months. Patients may have had neoadjuvant chemotherapy prior to surgery.
- •Patients must have normal renal function test and no prior renal disease. The screening cut off for serum creatinine is < 1.5mg/dL.
- •Patients must have normal hepatic function test and no prior liver disease: (1) The screening results for alanine aminotransferase (ALT) must be < 2 times the upper limit of normal. (2) The screening results for aspartate aminotransferase (AST), if available, must be < 2 times the upper limit of normal.
- •Patients who speak English or Spanish (due to the novel research and its complexity, we are only accruing English-speaking or Spanish-speaking patients to the protocol).
- •Patients must be willing and able to review, understand, and provide written consent.
- •Patients must be willing to discontinue taking dong quai and/or St. John's wort.
排除标准
- •Patients who are taking medications (including minocycline) or have conditions that potentially preclude use of the study medication or intervention as determined by the treating physician.
- •Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial.
- •Patients with a history of clinically significant cutaneous drug reaction, hypersensitivity reaction, anaphylaxis or any other serious adverse reaction to any of the anesthetics or analgesics medications used in the study.
- •Patients with hypersensitivity to any tetracycline.
- •Patients on vitamin K antagonist (i.e., warfarin).
- •Patients taking any tetracycline within the last 15 days.
- •Patients who have been on opioid therapy for the last 4 weeks or more.
- •Patients with bile duct obstruction.
- •Patients who are pregnant.
- •Patients with INR > 1.
- •Patients with autoimmune disease.
研究组 & 干预措施
Placebo
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery).
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
干预措施: Questionnaires (Behavioral)
Minocycline
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Minocycline100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
干预措施: Minocycline (Drug)
Minocycline
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Minocycline100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
干预措施: Questionnaires (Behavioral)
Placebo
Participants take study medication twice daily, starting 2 days prior to surgery, and continue for 3 weeks postsurgery. The final day of study medication will be the 21st day after surgery.
Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery).
Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy of Minocycline for Reducing Patient-Reported Symptoms
时间窗: -2 to 21 days post-dose
Primary outcome variable is area under the curve (AUC) using the average of the 3 most severe symptoms (pain, fatigue, and disturbed sleep) beginning 2 days prior to surgery and ending 21 days postsurgery. AUC calculated using trapezoidal approximation. The base of a trapezoid corresponds to the number of days between assessments while the heights correspond to 2 adjoining symptom responses. The number of trapezoids depends on the number of symptom assessments. The sum of the area for all the trapezoids represents the AUC of a particular patient. Data were collected to create the curve (-2, 0, 1, 3, 5, 7, 10, 14, 17, and 21 days post-dose)
次要结局
- Number of Participants Time-to-Symptom-Recovery(Day -2, Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, Day 20)