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

NCT03372148 | Withdrawn DMC FDA Device

• 1 other identifier: IRB00129556
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Head and Neck Cancer; Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in peak flow swallow measures

  9 months

Study Arms (1)

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

Diagnostic Test: pHRMi

Interventions

pHRMi DIAGNOSTIC_TEST

Pharyngeal High Resolution Manometry and Impedance swallowing function evaluation

pHRMi in evaluation of swallowing function

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (2)

SKCCC at Johns Hopkins (East Baltimore Campus)

Baltimore, Maryland, 21287, United States

Location

Suburban Hospital

Bethesda, Maryland, 20817, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Harry Quon, MD

  SKCCC at Johns Hopkins (East Baltimore Campus)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 13, 2017
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)