Head and Neck Cancer Treatment Related Dysphagia

Cancers located in the upper aerodigestive tract of the head and neck region present unique
management challenges due to the anatomic density of the region. These include (as for all
cancers) effective management of all clinically evident cancer cells and sub-clinical cancer
cells based on a knowledge of their anatomic location (2). For head and neck cancers, the
anatomic density of this region of the body presents a significant risk for cancer therapies
injuring important upper aerodigestive functions. In particular, swallowing function and its
dysfunction (ie. dysphagia) can have multi-faceted consequences for the head and neck cancer
patient including serious quality of life impairments (3) and the potential risk of late
mortality with evidence to date suggest that aspiration lung injury may be a major cause (1,
4). In fact, functional considerations have had a profound influence on the history of head
and neck cancer therapy development.

Historically, head and neck cancer management was managed surgically. Though oncologically
effective, the transcervical exposure technique along with the tissues removed during the
cancer extirpation led to increasing concerns about the functional impact of the therapy,
especially as increasing interest in preserving function was sought by investigators and
patients. As technical improvements in fractionated external beam radiotherapy (EBRT)
developed in the early 1980s, investigations evaluated and demonstrated that various
strategies to intensify EBRT with either concurrent chemotherapy or by altering the
radiotherapy fractionation schedule (ie. twice daily treatments) improved not only
local-regional tumour control rates but provided organ preservation. Studies now confirm that
the improved local-regional control rates translate into improved survival rates and have led
to their acceptance as standard-of-care (SOC) treatment options. While functional organ
preservation was often described as a goal of these investigations, the ability to rigorously
define and in fact measure organ function, especially swallow function, was often limited
with successful organ preservation largely reflecting the ability to determine anatomic
preservation (5). A major reason for this has been the limited spectrum of effective tools to
not only measure function (especially swallow function) but that lend themselves to repeated
systematic longitudinal use throughout a course of head and neck cancer treatment especially
in follow-up surveillance where manifestations can go unappreciated. As a result, the true
prevalence of treatment-related swallow dysfunction in head and neck cancer patients remains
unknown, an observation confirmed in a recent multi-national systematic review (6). As noted
by the Institute of Medicine, without the ability to measure, we cannot begin to improve upon
the outcome (7).

Measuring swallow function in HNSCC remains a particularly challenge as efforts continue to
strive towards the development of function preserving organ cancer therapy. It has arguably
taken on a greater prominence in light of the changing epidemiology of OPSCC (8, 9) where an
increasing number of OPSCC (oropharyngeal squamous cell cancer) patients have cancers
associated with the human papillomavirus (HPV) that have a favourable prognosis regardless of
whether surgical or non-surgical management approaches are undertaken (10). This changing
epidemiology, which some have described in epidemic proportions (9), suggests that an
increasing number of cancer survivors will be at risk of developing late complications
especially those related to swallow function. While arguably this tenet remains to be firmly
established, to do so highlights several challenges that are important to address. These
include establishing an effective strategy to longitudinally measure swallow function that
also reflects the cluster of other treatment-related symptoms that can affect swallow such as
taste changes and xerostomia (6). It requires not only a valid tool but one that lends itself
to repeat ease of use ideally within a patient's ecologic environment to minimize bias and
preferably within an infrastructure that readily curates this measure for analysis.

To address this problem, investigators propose to longitudinally apply the Sydney Swallow
Questionnaire (SSQ), a validated patient-reported outcome (PRO) instrument (11) that
evaluates many dimensions of swallow function before, during treatment and in follow-up care
of the head and neck cancer patient. The SSQ is particularly attractive as it is
patient-centric and reflects their sensation of swallow-related symptoms (ie. xerostomia)
which is important as the impact of sensory changes are otherwise not evaluated with other
swallow metrics that are available. More significantly, the SSQ is quantitative,
multi-dimensional (encompasses other swallow-related symptoms) and has discriminative power
as a swallow metric. Normal population assessments have defined SSQ scores that reflect
neurogenic and non-neurogenic dysphagia including cross-sectional studies in HNSCC patients.
Its longitudinal application however has not been evaluated to define the natural history and
prevalence of HNSCC-treatment related dysphagia. Lastly, our group has successfully validated
a Chinese version of the SSQ (relevant for the inclusion of nasopharyngeal cancer patients
due to the increase volume of the pharynx that is treated) and has developed an electronic
version of both the original English and Chinese versions of the SSQ that is accessible
through the web-portal of our Mosaiq/Oncospace® database that facilitates secure
HIPAA-compliant data curation across institutions.

Inclusion Criteria - Head and Neck Cancer Study Subjects:

1. Previously untreated head and neck cancer of any histology receiving treatment with
curative oncologic intent regardless of the treatment modality.

2. Capable of providing informed consent.

Inclusion Criteria - Non-Head and Neck Cancer Study Subjects

1. Previously untreated cancer of any histology with no prior history of swallowing
disorder and receiving radiation or concurrent chemoradiation or chemotherapy followed
by radiation or concurrent chemoradiation.

2. Screening SSQ <234 prior to any cancer treatment.

3. Capable of providing informed consent.

Exclusion Criteria -

1. 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.

2. Potential study subjects who have cognitive limitations / impairments that prevent a
potential study subject's ability to provide self-reporting with the SSQ instrument
and/or other data elements required as described in the study calendar.

3. Potential study subjects who have motor skill limitations that prevent a potential
study subject's ability to provide self-reporting with the SSQ instrument and/or other
data elements required as described in the study calendar.