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

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.

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.