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

Primary Purpose

Head and Neck Cancer, Oropharynx Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prophylactic Swallowing Home Exercise Program
Clinician-Directed Prophylactic Swallowing Exercises
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Prophylactic Swallowing Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

G1 - Clinician-Directed Therapy

G2 - Patient-Directed Home Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in swallowing status as measured by FOIS
FOIS has a range from 0 (most restrictive) to 7 (least restrictive).
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).
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.
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.
Proportion of patients requiring further swallowing therapy
Proportion of patients requiring further swallowing therapy post study intervention as per treating physician discretion
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).

Full Information

First Posted
February 9, 2018
Last Updated
January 26, 2021
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT03435471
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
July 17, 2020 (Actual)
Study Completion Date
January 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Oropharynx Cancer
Keywords
Prophylactic Swallowing Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G1 - Clinician-Directed Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
G2 - Patient-Directed Home Therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Prophylactic Swallowing Home Exercise Program
Intervention Description
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
Intervention Name(s)
Clinician-Directed Prophylactic Swallowing Exercises
Intervention Description
Once weekly face-to-face meetings with a study speech pathologist for a total of six sessions, to participate in active swallowing exercises
Primary Outcome Measure Information:
Title
Change in swallowing status
Description
Swallowing status will be measured using Functional Oral Intake Scale (FOIS). FOIS has a range from 0 (most restrictive) to 7 (least restrictive).
Time Frame
Baseline, Up to 6 weeks
Secondary Outcome Measure Information:
Title
Change in swallowing status as measured by FOIS
Description
FOIS has a range from 0 (most restrictive) to 7 (least restrictive).
Time Frame
Baseline, Up to 30 weeks
Title
Change in quality of life as measured by PSS-HN
Description
Performance Status Scale - Head and Neck (PSS-HSN) is a questionnaire with a total score ranging from 100 (normal function) to 0 (limited function).
Time Frame
Baseline to 6 weeks, Baseline to 30 weeks
Title
Change in quality of life as measured by EAT-10
Description
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.
Time Frame
Baseline to 6 weeks, Baseline to 30 weeks
Title
Change in quality of life as measured by UW-QOL
Description
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.
Time Frame
Baseline to 6 weeks, Baseline to 30 weeks
Title
Proportion of patients requiring further swallowing therapy
Description
Proportion of patients requiring further swallowing therapy post study intervention as per treating physician discretion
Time Frame
Baseline to 6 weeks, Baseline to 30 weeks
Title
Change in Pharyngeal Swallowing Efficiency and Safety as measured by DIGEST Safety Grade
Description
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).
Time Frame
Baseline to 6 weeks, Baseline to 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna S Lundy, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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