跳至主要内容
临床试验/NCT03372148
NCT03372148撤回不适用

Evaluating the Role of Pharyngeal High Resolution Manometry and Impedance (pHRMi) in the Longitudinal Evaluation of Swallow Function in Head and Neck Cancer Patients

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2 个研究点 分布在 1 个国家开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in swallowing function as assessed by serial pHRMi

研究概览

简要总结

Examining if the use of serial pHRMi to identify biomechanical changes in the swallow function of HNC patients treated with radiotherapy.

详细描述

Cancers located in the upper aerodigestive tract of the head and neck (HN) region present unique management challenges due to the crucial functions in this anatomic region along with its anatomic density. As such, cancers and the actual treatment can be functionally debilitating. Of these, the ability to effectively and safely transport a swallow bolus from the oral cavity to the esophagus is particularly important. This consideration has had a major influence regarding the optimal management for head and neck cancers as both oncologically effective and function-preserving therapies are desired. Accomplishing this therapeutic goal has been elusive due to a lack of tools that effectively and longitudinally evaluate swallow function over the course of a treatment and in follow-up. Standard of care approaches including modified barium swallow studies are typically used to characterize dysphagia once a clinical event has occurred such as pneumonia. As such, clinicians surprisingly lack a clear understanding of the natural history of head and neck cancer treatment - related swallow dysphagia (HNCTD) regardless of the treatment modality. Understanding which patient has HNCTD is especially important given increasing evidence that demonstrates that late secondary aspiration contributes to non-cancer related mortality in head and neck (HN) cancer patients.

To address this problem, the investigator hypothesizes that the use of quantitative and validated approaches to measuring dysphagia will allow the investigators to better define the heterogeneity seen in patients with dysphagia to gain insights into its prevention including the mortality risk of aspiration pneumonia the investigators recently demonstrated 1. Work to date using the quantitative patient-reported outcome (PRO) instruments, the Sydney Swallow Questionnaire (SSQ) and the MD Anderson Dysphagia Inventory (MDADI) has demonstrated that a reproducible signature of swallow scores can define dysphagia in irradiated HNC patients. Pilot work to date has also demonstrated that pressure flow analysis (PFA) with artificial neural network (ANN) of pharyngeal high resolution manometry and impedance (pHRMi) studies in a heterogeneous cohort of HNC patients can significantly predict for the risk of clinical aspiration and for pneumonia. This pilot study will investigate the use of serial pHRMi to identify biomechanical changes in the swallow function of HNC patients treated with radiotherapy and secondarily evaluate how the PFA may add to the investigators current PRO-defined swallow signature.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Previously untreated head and neck cancer of any histology receiving radiation with curative oncologic intent regardless of the treatment modality.
  • •The radiation can be with or without prior surgery as part of the untreated HNC treatment plan.
  • •The radiation can include concurrent chemotherapy or without.
  • •Capable of providing informed consent.

排除标准

  • •Potential study subjects with contraindications for the HRMi procedure:
  • •Potential study subjects with altered mental status or obtundation.
  • •Potential study subjects who cannot understand or follow instructions.
  • •Potential study subjects with suspected or known obstruction precluding safe passage of the manometry catheter.
  • •Potential study subjects who are unwilling or unable to be adherent to longitudinal assessment and follow-up. This will include potential study subjects who have poor performance status at the time of study enrollment evaluation.
  • •Potential study subjects who have cognitive limitations / impairments that prevent a potential study subject's ability to provide self-reporting with the SSQ and the MDADI instrument.
  • •Potential study subjects who have motor skill limitations that prevent a potential study subject's ability to provide self-reporting with the SSQ and MDADI instrument.

研究组 & 干预措施

pHRMi in evaluation of swallowing function

Experimental

Pharyngeal High Resolution Manometry and Impedance (pHRMi) evaluation of swallowing function at baseline, 3 months post radiation, then at 9 months

干预措施: pHRMi (Diagnostic Test)

结局指标

主要结局

Change in swallowing function as assessed by serial pHRMi

时间窗: Baseline, 3 months 9 months

Use of serial pHRMi to identify biomechanical changes in the swallow function of HNC patients treated with radiotherapy.

次要结局

  • Change in peak flow swallow measures(9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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