Role of Pharyngeal High Resolution Manometry and Impedance in Swallow Function of Head and Neck Cancer Patients

Head and Neck Cancer Clinical Trial

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

Status Withdrawn

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Dysphagia
• Head and Neck Cancer
• Head and Neck Neoplasms

• NCT number: NCT03372148
• Study type: Interventional
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Status: Withdrawn
• Phase: N/A
• Start date: December 2023
• Completion date: December 2030