Analysis of Analgesia Regimens During Concurrent Chemoradiation for Head and Neck Cancer: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of side effects or drug intolerance
研究概览
简要总结
This randomized pilot clinical trial studies the side effects of gabapentin and how well it works when given together with methadone hydrochloride and oxycodone hydrochloride in improving quality of life in patients with stage II-IV head and neck cancer during chemoradiation. Gabapentin, methadone hydrochloride, and oxycodone hydrochloride may help relieve moderate or severe pain caused by head and neck cancer during and after chemoradiation therapy.
详细描述
PRIMARY OBJECTIVES:
I. Collect preliminary data on the safety and efficacy of two analgesic regimens that can be used to design larger studies for comparing such regimens.
SECONDARY OBJECTIVES:
I. Examine effects of the treatment regimens on pain control, oral mucositis, and quality-of-life ratings scores during and after chemoradiation therapy (CRT).
TERTIARY OBJECTIVES:
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
- None
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 are eligible for chemoradiation therapy of the head and neck
- •Baseline creatinine (Cr) no greater than 1.5 times the upper limit of normal
- •Have a clinical stage II-IV head and neck carcinoma
- •Have a pathologic diagnosis of squamous cell carcinoma of the head and neck region
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- •Ability to swallow and retain oral medication or take through a feeding tube
- •Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- •Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Patients who have previously been treated with surgery or radiation for head and neck cancer and/or are being treated for recurrent head and neck cancer
- •Patients with known brain metastases will be excluded from this clinical trial
- •Any patients prescribed medications for chronic pain and/or neuropathy will be excluded, including patients under treatment of a pain specialist or substance-abuse programs
- •Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant or nursing female patients
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
- •Received an investigational agent within 30 days prior to enrollment
- •Patients on medications that prolong QT interval
- •Patients on dialysis or with transplanted organs
- •Patients already enrolled on other studies of systemic pain control agents
研究组 & 干预措施
Arm I (gabapentin)
Patients receive gabapentin PO TID for up to 7 weeks during radiotherapy.
All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).
干预措施: Gabapentin (Drug)
Arm I (gabapentin)
Patients receive gabapentin PO TID for up to 7 weeks during radiotherapy.
All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).
干预措施: Quality-of-Life Assessment (Other)
Arm I (gabapentin)
Patients receive gabapentin PO TID for up to 7 weeks during radiotherapy.
All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).
干预措施: Questionnaire Administration (Other)
Arm II (gabapentin, methadone, oxycodone)
Patients receive gabapentin PO TID, methadone hydrochloride PO BID, and oxycodone hydrochloride PO Q8H PRN for up to 7 weeks during radiotherapy.
All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).
干预措施: Gabapentin (Drug)
Arm II (gabapentin, methadone, oxycodone)
Patients receive gabapentin PO TID, methadone hydrochloride PO BID, and oxycodone hydrochloride PO Q8H PRN for up to 7 weeks during radiotherapy.
All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).
干预措施: Methadone Hydrochloride (Drug)
Arm II (gabapentin, methadone, oxycodone)
Patients receive gabapentin PO TID, methadone hydrochloride PO BID, and oxycodone hydrochloride PO Q8H PRN for up to 7 weeks during radiotherapy.
All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).
干预措施: Oxycodone Hydrochloride (Drug)
Arm II (gabapentin, methadone, oxycodone)
Patients receive gabapentin PO TID, methadone hydrochloride PO BID, and oxycodone hydrochloride PO Q8H PRN for up to 7 weeks during radiotherapy.
All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).
干预措施: Quality-of-Life Assessment (Other)
Arm II (gabapentin, methadone, oxycodone)
Patients receive gabapentin PO TID, methadone hydrochloride PO BID, and oxycodone hydrochloride PO Q8H PRN for up to 7 weeks during radiotherapy.
All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Incidence of side effects or drug intolerance
时间窗: Up to 24 months
Will be graded and recorded. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate. The frequency of toxicities will be tabulated by grade by treatment arm.
Change in pain levels via Oral Mucositis Daily Questionnaire (OMDQ), European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30, Head and Neck Quality of Life Survey, and physical evaluations
时间窗: Baseline to up to 24 months
Evaluated using a repeated measures model. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.
Proportion of patients who require higher equivalents of narcotic support added to their analgesia regimen in each arm
时间窗: Up to 24 months
Each patient requiring rescue medication for breakthrough or refractory pain will be counted as a failure for that specific regimen. At the end of the trial, number of failures will be compared between the two treatment arms using Fisher's exact test. Total amount of opioid intake mean will be compared using a t-test between the two arms. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate
次要结局
- Change in quality of life rating scores during and after CRT, using the EORTC QLQ-C30 and H&N35(Baseline to up to 24 months)
- Change in oral mucositis rating scores during and after CRT, using the OMDQ(Baseline to up to 24 months)