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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Head and Neck Cancer; Dysphagia
• Intervention / Treatment: Diagnostic test: pHRMi

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • SKCCC at Johns Hopkins (East Baltimore Campus)
    • Bethesda, Maryland, United States, 20817
      • Suburban Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Previously untreated head and neck cancer of any histology receiving radiation with curative oncologic intent regardless of the treatment modality.

   1. The radiation can be with or without prior surgery as part of the untreated HNC treatment plan.
   2. The radiation can include concurrent chemotherapy or without.
2. Capable of providing informed consent.

Exclusion Criteria:

1. Potential study subjects with contraindications for the HRMi procedure:

   1. Potential study subjects with altered mental status or obtundation.
   2. Potential study subjects who cannot understand or follow instructions.
   3. Potential study subjects with suspected or known obstruction precluding safe passage of the manometry catheter.
2. 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.
3. 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.
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pHRMi in evaluation of swallowing function; Pharyngeal High Resolution Manometry and Impedance (pHRMi) evaluation of swallowing function at baseline, 3 months post radiation, then at 9 months	Diagnostic test: pHRMi; Pharyngeal High Resolution Manometry and Impedance swallowing function evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in swallowing function as assessed by serial pHRMi	Use of serial pHRMi to identify biomechanical changes in the swallow function of HNC patients treated with radiotherapy.	Baseline, 3 months 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peak flow swallow measures	Analyze data to develop a classifier model for swallow function.	9 months

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2023
• Primary Completion (Anticipated): December 1, 2027
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: IRB00129556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No