Status:
WITHDRAWN
Role of Pharyngeal High Resolution Manometry and Impedance in Swallow Function of Head and Neck Cancer Patients
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Head and Neck Cancer
Dysphagia
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Examining if the use of serial pHRMi to identify biomechanical changes in the swallow function of HNC patients treated with radiotherapy.
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 dens...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2030
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03372148
Start Date
December 1 2023
End Date
December 1 2030
Last Update
April 26 2023
Active Locations (2)
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1
SKCCC at Johns Hopkins (East Baltimore Campus)
Baltimore, Maryland, United States, 21287
2
Suburban Hospital
Bethesda, Maryland, United States, 20817