A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale
研究概览
简要总结
This randomized pilot clinical trial studies dexamethasone in reducing oral pain and dry mouth after surgery in patients with oropharyngeal cancer. Dexamethasone may help lower pain and dry mouth caused by surgery.
详细描述
PRIMARY OBJECTIVES:
I. To prospectively determine if a longer 4-day course of dexamethasone (or equivalent) for the management of postoperative pain and dysphagia following transoral robotic surgery (TORS) is superior to the current standard of a single injection of dexamethasone 10 mg.
SECONDARY OBJECTIVES:
I. Determine the effect of postoperative corticosteroids on postoperative dysphagia following TORS.
II. Determine the effect of postoperative corticosteroids on length of hospital stay following TORS.
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 must be diagnosed with oropharyngeal squamous cell carcinoma (SCC) that are surgical candidates
- •Macroscopic resection of the tumor via TORS must be planned with curative intent
- •Patient must be willing to remain on corticosteroid therapy for 4 days postoperatively
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients with known distant metastases or other malignancies
- •Patients with a history of allergy or adverse reaction to corticosteroids
- •Patients with a history of diabetes
- •Patients with fasting capillary blood glucose of > 140 on the day of surgery
- •Patients on chronic corticosteroids
- •Chronic alcohol abuse (> 6 alcoholic beverages daily)
- •Patients with a history of severe chronic pain on high dose narcotics (> 25 mg of oxycodone or equivalent daily) preceding diagnosis of cancer
- •Patients taking significant cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers, i.e. protease inhibitors (ritonavir, nelfinavir, etc), clarithromycin, ketoconazole, fluconazole, verapamil, diltiazem, carbamazepine, phenytoin, phenobarbital, Rifampin, efavirenz, nevirapine
- •Patients who have received any investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study
- •Patients who will undergo complex head and neck surgery in addition to the TORS procedure requiring reconstruction with a free flap
- •Patients who have had any previous head and neck surgery that has affected swallowing, voice or speech or who have had previous radiation to the head or neck
- •Patients who have any confounding medical or neurological conditions that have the potential to affect cognition, speech or swallowing function; i.e. stroke, neurodegenerative disease, neuromuscular movement disorders, head injury, etcetera
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Excluded patients will be allowed to participate in the trial on an observational basis only
研究组 & 干预措施
Arm I (treatment)
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
干预措施: Dexamethasone (Drug)
Arm I (treatment)
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
干预措施: Quality-of-Life Assessment (Procedure)
Arm II (control)
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
干预措施: Quality-of-Life Assessment (Procedure)
Arm I (treatment)
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
干预措施: Questionnaire Administration (Other)
Arm I (treatment)
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
干预措施: Transoral Robotic Surgery (Procedure)
Arm II (control)
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
干预措施: Dexamethasone (Drug)
Arm II (control)
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
干预措施: Placebo (Other)
Arm II (control)
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
干预措施: Questionnaire Administration (Other)
Arm II (control)
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
干预措施: Transoral Robotic Surgery (Procedure)
结局指标
主要结局
Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale
时间窗: 21 days
Visual Analog Scale (VAS) is a 0-10 scale for patients to indicate intensity level of pain with 0 indicating "No pain" and 10 indicating "Worst possible, unbearable, excruciating pain". A descriptive time plot of VAS scores will be produced for all enrolled subjects, with loess curve fitted separately for the experimental and control groups. A linear mixed effects model will be used to compare the pain VAS scores between the experimental and control groups.
次要结局
- Eating Assessment Tool (EAT)-10 Scores(Up to 12 months)
- Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)(Up to 21 days)
- Complications Associated With Postoperative Corticosteroid Use After TORS(Up to 30 days)
- PSS Normalcy of Diet(30 days)
- Opioid Use(3 days)
- UM-QOL Eating(21 days)
- Days With Feeding Tube(12 months)
研究者
Daniel Clayburgh
Assistant Professor
OHSU Knight Cancer Institute