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

NCT03435471 | Completed DMC

• 1 other identifier: 20180084
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Oropharynx Cancer

Keywords

Prophylactic Swallowing Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in swallowing status as measured by FOIS

  Baseline, Up to 30 weeks

• Change in quality of life as measured by PSS-HN

  Baseline to 6 weeks, Baseline to 30 weeks

• Change in quality of life as measured by EAT-10

  Baseline to 6 weeks, Baseline to 30 weeks

• Change in quality of life as measured by UW-QOL

  Baseline to 6 weeks, Baseline to 30 weeks

• Proportion of patients requiring further swallowing therapy

  Baseline to 6 weeks, Baseline to 30 weeks

Study Arms (2)

G1 - Clinician-Directed Therapy

EXPERIMENTAL

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; Other: Clinician-Directed Prophylactic Swallowing Exercises

G2 - Patient-Directed Home Therapy

ACTIVE COMPARATOR

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

Interventions

Prophylactic Swallowing Home Exercise Program 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.

G1 - Clinician-Directed Therapy; G2 - Patient-Directed Home Therapy

Clinician-Directed Prophylactic Swallowing Exercises OTHER

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

G1 - Clinician-Directed Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of head and neck cancer (sites: oropharynx: human papillomavirus (HPV) related and non HPV related tonsil and base of tongue)
• Scheduled to undergo definitive chemoradiation therapy
• At least 18 years of age or older
• Subject must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Surgical management in addition to chemoradiation therapy;
• Cancer of the sinus, brain, or parotid;
• Prior treatment for head and neck cancer;
• Receiving chemoradiation treatment at an outside institution (i.e., non-University of Miami (UM) clinic);
• Prior history of dysphagia unrelated to the current diagnosis of head and neck cancer;
• Prior neurologic disorder (i.e., Cerebrovascular accident (CVA), Traumatic brain injury (TBI), dementia) or current degenerative neuromuscular disease;
• History of prior c-spine surgery;
• History of prior vocal fold immobility

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Donna S Lundy, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 19, 2018
• Study Start: September 17, 2018
• Primary Completion: July 17, 2020
• Study Completion: January 13, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)