Clinical trial NCT03435471: Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer
Official title: Does the Use of Clinician Directed Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer Improve Swallowing Function Outcomes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Oropharynx Cancer
Keywords: Prophylactic Swallowing Therapy
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in swallowing status
timeFrame: Baseline, Up to 6 weeks
Secondary outcomes:
measure: Change in swallowing status as measured by FOIS
timeFrame: Baseline, Up to 30 weeks
measure: Change in quality of life as measured by PSS-HN
timeFrame: Baseline to 6 weeks, Baseline to 30 weeks
measure: Change in quality of life as measured by EAT-10
timeFrame: Baseline to 6 weeks, Baseline to 30 weeks
measure: Change in quality of life as measured by UW-QOL
timeFrame: Baseline to 6 weeks, Baseline to 30 weeks
measure: Proportion of patients requiring further swallowing therapy
timeFrame: Baseline to 6 weeks, Baseline to 30 weeks
measure: Change in Pharyngeal Swallowing Efficiency and Safety as measured by DIGEST Safety Grade
timeFrame: Baseline to 6 weeks, Baseline to 30 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Donna S Lundy, PhD
role: PRINCIPAL_INVESTIGATOR
References: