Clinical trial · Interventional
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
NCT03372148CI-TRIAL-00065964withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study withdrawn by PI
Summary
Brief summary (as posted)
Examining if the use of serial pHRMi to identify biomechanical changes in the swallow function of HNC patients treated with radiotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pHRMi | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pHRMi in evaluation of swallowing function
- description
- Pharyngeal High Resolution Manometry and Impedance (pHRMi) evaluation of swallowing function at baseline, 3 months post radiation, then at 9 months
- interventionNames
- Diagnostic Test: pHRMi
Primary outcomes (1)
- measure
- Change in swallowing function as assessed by serial pHRMi
- timeFrame
- Baseline, 3 months 9 months
- description
- Use of serial pHRMi to identify biomechanical changes in the swallow function of HNC patients treated with radiotherapy.
Secondary outcomes (1)
- measure
- Change in peak flow swallow measures
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.