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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Oropharynx Cancer
• Intervention / Treatment: Other: Prophylactic Swallowing Home Exercise Program; Other: Clinician-Directed Prophylactic Swallowing Exercises

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).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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.; 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
Active Comparator: 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	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in swallowing status	Swallowing status will be measured using Functional Oral Intake Scale (FOIS). FOIS has a range from 0 (most restrictive) to 7 (least restrictive).	Baseline, Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in swallowing status as measured by FOIS	FOIS has a range from 0 (most restrictive) to 7 (least restrictive).	Baseline, Up to 30 weeks
Change in quality of life as measured by PSS-HN	Performance Status Scale - Head and Neck (PSS-HSN) is a questionnaire with a total score ranging from 100 (normal function) to 0 (limited function).	Baseline to 6 weeks, Baseline to 30 weeks
Change in quality of life as measured by EAT-10	Eating Assessment Tool-10 (EAT-10) is a questionnaire with a total score ranging from 0 to 40 with the lower score indicating better function.	Baseline to 6 weeks, Baseline to 30 weeks
Change in quality of life as measured by UW-QOL	University of Washington Quality of Life (UW-QOL) is a questionnaire with a total score ranging from 0 to 100 with the higher score indicating poorer health outcomes.	Baseline to 6 weeks, Baseline to 30 weeks
Proportion of patients requiring further swallowing therapy	Proportion of patients requiring further swallowing therapy post study intervention as per treating physician discretion	Baseline to 6 weeks, Baseline to 30 weeks
Change in Pharyngeal Swallowing Efficiency and Safety as measured by DIGEST Safety Grade	DIGEST is a measure of pharyngeal swallowing efficiency and safety. The DIGEST measure incorporates 2 measures: Safety as determined by the Penetration Aspiration Scale with a score ranging from 0 (safe) to 4 (life-threatening unsafe); and; Efficiency as determined by the quantity of residue observed on the videoflouroscopic swallowing study with a score ranging from 0 (efficient) to 4 (life-threatening inefficiency). These two measures combine for an overall score, ranging from 0 (no pharyngeal dysphagia) to 4 (life-threatening dysphagia).	Baseline to 6 weeks, Baseline to 30 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Donna S Lundy, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2018
• Primary Completion (Actual): July 17, 2020
• Study Completion (Actual): January 13, 2021

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Prophylactic Swallowing Therapy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Head and Neck Neoplasms; Oropharyngeal Neoplasms
• Other Study ID Numbers: 20180084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No