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

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ClinicalTrials.gov Identifier: NCT03372148
Recruitment Status : Not yet recruiting
First Posted : December 13, 2017
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Dysphagia Diagnostic Test: pHRMi Not Applicable

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 themselves 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, we 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 us to better define the heterogeneity seen in patients with dysphagia to gain insights into its prevention including the mortality risk of aspiration pneumonia our group 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 our current PRO-defined swallow signature.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pharyngeal High Resolution Manometry and Impedance (pHRMi) in the Longitudinal Evaluation of Swallow Function in Head and Neck Cancer Patients
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in swallowing function [ Time Frame: Baseline, 3 months and then at 9 months ]
    Use of serial pHRMi to identify biomechanical changes in the swallow function of HNC patients treated with radiotherapy.


Secondary Outcome Measures :
  1. Change in peak flow swallow measures [ Time Frame: 9 months ]
    Analyze data to develop a classifier model for swallow function.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372148


Contacts
Contact: Harry Quon, MD 410-502-3877 hquon2@jhmi.edu

Locations
United States, Maryland
SKCCC at Johns Hopkins (East Baltimore Campus) Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Harry Quon, MD    410-502-3877    hquon2@jhmi.edu   
Sub-Investigator: Rina Abrams, MS         
Sub-Investigator: Alba Azola         
Sub-Investigator: Michael Bowers, MS         
Sub-Investigator: Carole Fakhry, MD         
Sub-Investigator: Christine Gourin, MD         
Sub-Investigator: Peng Huang, PhD         
Sub-Investigator: Xuan Hui         
Sub-Investigator: Ana Ponce Kiess, MD         
Sub-Investigator: Todd McNutt, PhD         
Sub-Investigator: William Ravich, MD         
Sub-Investigator: Ellen Stein, MD         
Sub-Investigator: Kimberly Webster, MA         
Suburban Hospital Not yet recruiting
Bethesda, Maryland, United States, 20817
Contact: Brandi Page, MD    301-896-2012    bpage5@jhmi.edu   
Principal Investigator: Brandi Page, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
Principal Investigator: Harry Quon, MD SKCCC at Johns Hopkins (East Baltimore Campus)

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03372148     History of Changes
Other Study ID Numbers: IRB00129556
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms