Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer

NCT ID: NCT03435471

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2021-01-13

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).

Conditions

Head and Neck Cancer; Oropharynx Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

G1 - Clinician-Directed Therapy

Clinician-Directed Weekly Swallowing Therapy: Once weekly face-to-face meetings with a study speech pathologist for a total of six sessions, to participate in active swallowing exercises and review the home swallowing exercise program. Each session will last 30 minutes +/- ten minutes. Other assessments include:

• Clinician-Directed Prophylactic Swallowing Exercises
• Prophylactic Swallowing Home Exercise Program
• Penetration/Aspiration Scale (PAS)
• Functional Oral Intake Scale (FOIS)
• Eating Assessment Tool-10 (EAT-10)
• University of Washington Quality of Life (UW-QOL)
• Performance Status Scale for Head and Neck Cancer Patients (PSS-HN)
• DIGEST Safety Grade

Group Type: EXPERIMENTAL

Prophylactic Swallowing Home Exercise Program

Intervention Type: OTHER

The home exercise program will consist of six exercises that are recommended to be practiced three times per day. Subjects will complete a weekly exercise log to track compliance.

Clinician-Directed Prophylactic Swallowing Exercises

Intervention Type: OTHER

Once weekly face-to-face meetings with a study speech pathologist for a total of six sessions, to participate in active swallowing exercises

G2 - Patient-Directed Home Therapy

Patient-Directed Home Swallowing Therapy: One face-to-face meeting with a study speech pathologist prior to initiation of treatment. During that session, they will be encouraged to practice the given exercises independently on a specific daily schedule regime throughout their treatment. Other assessments include:

• Prophylactic Swallowing Home Exercise Program
• Penetration/Aspiration Scale (PAS)
• Functional Oral Intake Scale (FOIS)
• Eating Assessment Tool-10 (EAT-10)
• University of Washington Quality of Life (UW-QOL)
• Performance Status Scale for Head and Neck Cancer Patients (PSS-HN)
• DIGEST Safety Grade

Group Type: ACTIVE_COMPARATOR

Prophylactic Swallowing Home Exercise Program

Intervention Type: OTHER

The home exercise program will consist of six exercises that are recommended to be practiced three times per day. Subjects will complete a weekly exercise log to track compliance.

Interventions

Prophylactic Swallowing Home Exercise Program

The home exercise program will consist of six exercises that are recommended to be practiced three times per day. Subjects will complete a weekly exercise log to track compliance.

Intervention Type: OTHER

Clinician-Directed Prophylactic Swallowing Exercises

Once weekly face-to-face meetings with a study speech pathologist for a total of six sessions, to participate in active swallowing exercises

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Donna S. Lundy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donna S Lundy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20180084

Identifier Type: -

Identifier Source: org_study_id