NCT04128267终止不适用
Characterization of Central Pain Syndrome in Survivors of Head and Neck Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive Pain
研究概览
简要总结
This is a cross-sectional pilot study of head and neck cancer survivors who have completed multi-modal treatment to assess and characterize the presence of distinct pain syndromes.
详细描述
Primary objectives:
- To correlate structural and functional MRI signature with one of three pain phenotypes in head and neck cancer survivors: 1) no pain, 2) central pain, and 3) nociceptive pain.
- To correlate the presence of chronic systemic symptoms with pain phenotype
Exploratory objectives:
- DNA, RNA, and plasma will be collected for genomic, transcriptomic, and proteomic studies. Results will be vertically integrated along with the results of clinical studies described within this protocol to identify targets for future correlative studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with histologically proven head and neck cancer
- •Patients without a diagnosis of head and neck cancer (up to 10 patients, see below)
- •We anticipate enrolling a total of 75 patients with a history of head and neck cancer who will complete all questionnaires and MRI scanning. We will also recruit up to 10 patients WITHOUT a diagnosis of head and neck cancer to facilitate optimization of the MRI scanning processes. This will allow us to address logistical issues, such as pressure stimulator setup and timing of each scan to be performed.
- •Completed multi-modality therapy a minimum of 6 weeks prior to study entry.
- •Willing and able to provide informed consent
- •All participants must be at least 21 years of age
- •Able to speak English
排除标准
- •Patients who are pregnant
- •Patients who are unable to lie still
- •Patients who are unable tolerate pressure stimulator
- •Non-MRI compatible devices such as aneurysm clips, cardiac pacemakers or defibrillators, cochlear implants, hardware, or any other implants
- •Iron-based tattoos, pieces of metal (bullet, BB, shrapnel) close to or in an important organ (such as the eye), or other non-MRI compatible metal in the body
结局指标
主要结局
Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive Pain
时间窗: Approximately 8 weeks
MRI scan of brain to measure response to stimulated pressure to thumbnail
Magnetic Resonance Imaging (MRI) to Correlate Presence of Chronic Systemic Symptoms With Pain Phenotype
时间窗: Approximately 8 weeks
MRI scan of brain to measure response to stimulated pressure to thumbnail
次要结局
未报告次要终点
研究者
Dianne Lou
Principal Investigator
Vanderbilt-Ingram Cancer Center
研究点 (2)
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