Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | September 17, 2018 |
| End Date: | August 2021 |
Does the Use of Clinician Directed Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer Improve Swallowing Function Outcomes?
Clinician directed prophylactic swallowing therapy will improve immediate (four weeks +/- two
weeks) and short-term (26 weeks +/- four weeks) post-treatment swallowing function and
quality of life versus patient directed home exercises.
The purpose of this prospective, interventional, pilot investigation is to determine whether
clinician directed swallowing therapy will improve patient swallowing function outcomes and
quality of life in the immediate and short-term basis compared to patients receiving standard
of care patient directed independent home swallowing therapy. Patient compliance with home
exercises programs is reportedly inconsistent. Patients may experience changes in their
physical functioning and overall well-being that may impact their ability to follow-through
with independent home therapy. Clinician directed swallowing therapy allows for ongoing
assessment of changes that may warrant modifying the therapy program in terms of intensity of
exercises and/or expectations. This facilitates individualizing the patient's therapy plan to
maximize their function and ability to achieve goals. It is anticipated that individualizing
swallowing therapy through weekly session will result in improved swallowing function.
weeks) and short-term (26 weeks +/- four weeks) post-treatment swallowing function and
quality of life versus patient directed home exercises.
The purpose of this prospective, interventional, pilot investigation is to determine whether
clinician directed swallowing therapy will improve patient swallowing function outcomes and
quality of life in the immediate and short-term basis compared to patients receiving standard
of care patient directed independent home swallowing therapy. Patient compliance with home
exercises programs is reportedly inconsistent. Patients may experience changes in their
physical functioning and overall well-being that may impact their ability to follow-through
with independent home therapy. Clinician directed swallowing therapy allows for ongoing
assessment of changes that may warrant modifying the therapy program in terms of intensity of
exercises and/or expectations. This facilitates individualizing the patient's therapy plan to
maximize their function and ability to achieve goals. It is anticipated that individualizing
swallowing therapy through weekly session will result in improved swallowing function.
This is a single-site, two-arm, 1:1 randomized, prospective, interventional, pilot study to
determine whether clinician directed swallowing therapy will improve patient swallowing
function outcomes when compared to patient-directed home-based swallowing therapy.
The investigators anticipate at least 40 subjects will need to be enrolled/consented in order
to obtain the accrual goal of 15 evaluable subjects for each group for a total of 30
participants.
All subjects in each group will receive a face-to-face education session with a speech
pathologist to review a recommended program of swallowing exercises prior to initiation of
chemoradiation at their baseline (pre-treatment evaluation session).
determine whether clinician directed swallowing therapy will improve patient swallowing
function outcomes when compared to patient-directed home-based swallowing therapy.
The investigators anticipate at least 40 subjects will need to be enrolled/consented in order
to obtain the accrual goal of 15 evaluable subjects for each group for a total of 30
participants.
All subjects in each group will receive a face-to-face education session with a speech
pathologist to review a recommended program of swallowing exercises prior to initiation of
chemoradiation at their baseline (pre-treatment evaluation session).
Inclusion Criteria:
1. Diagnosis of head and neck cancer (sites: oropharynx: human papillomavirus (HPV)
related and non HPV related tonsil and base of tongue)
2. Scheduled to undergo definitive chemoradiation therapy
3. At least 18 years of age or older
4. Subject must have the ability to understand and the willingness to sign a written
informed consent document.
Exclusion Criteria:
1. Surgical management in addition to chemoradiation therapy;
2. Cancer of the sinus, brain, or parotid;
3. Prior treatment for head and neck cancer;
4. Receiving chemoradiation treatment at an outside institution (i.e., non-University of
Miami (UM) clinic);
5. Prior history of dysphagia unrelated to the current diagnosis of head and neck cancer;
6. Prior neurologic disorder (i.e., Cerebrovascular accident (CVA), Traumatic brain
injury (TBI), dementia) or current degenerative neuromuscular disease;
7. History of prior c-spine surgery;
8. History of prior vocal fold immobility
We found this trial at
1
site
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Donna S Lundy, PhD
Phone: 305-243-4315
University of Miami A private research university with more than 15,000 students from around the...
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