The Effect of Prophylactic Swallowing Exercises on Head and Neck Cancer Patients

December 3, 2015 updated by: Icahn School of Medicine at Mount Sinai
The purpose of this study is to find out if doing prophylactic or preventative swallowing exercises from the start of cancer treatment can improve the ability to swallow when the treatment is completed and beyond.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Type: Prospective Randomized Clinical Trial

Introduction:

Organ sparing treatment for advanced head and neck cancer can affect the swallowing mechanism via fibrosis of the structures responsible for effective and efficient bolus movement from the oral cavity and through the pharynx into the esophagus. This fibrosis may result in significant impairment of bolus transport. Range of motion exercises for the swallowing structures may decrease the fibrotic effects of the radiation treatment and improve swallowing outcomes after treatment.

Intervention:

Patients who have been diagnosed with head and neck cancer and who will be receiving radiation therapy either with or without chemotherapy as cancer treatment will be randomized to one of two swallowing treatment protocols. The first protocol will include the initiation of intensive swallowing exercises to begin at the start of the cancer treatment. The second treatment protocol will include the standard of care which provides swallowing evaluation and treatment once symptoms of swallowing dysfunction are experienced by the patient. Patients will not be given a choice of swallowing protocol. Those patients randomized to the intensive therapy protocol will be required to participate in weekly swallowing therapy sessions either in person or over the phone and perform the learned swallowing exercises three times a day. In addition, these patients will document their swallowing practice on a daily basis. The same investigator will provide all the swallowing treatment assuring that all patients get the same treatment approach.

All patients will fill out a questionnaire about their swallowing ability called the Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N). This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. This questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment. In addition, the nature of the patient's oral intake will be documented by the investigator using the Functional Oral Intake Scale (FOIS) which is a seven point scale of diet tolerance. This will be performed at the same intervals as the PSS-H&N. Presence or absence of PEG feedings will also be documented at these same times. These scales will then be used to compare the swallowing outcomes of the patients in the two different treatment protocols.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Patient diagnosed with head and neck cancer who will be receiving radiation therapy either alone of with chemotherapy as their treatment modality.

Exclusion criteria:

  • Patients with a history of neurologic disease
  • Patients with previous head and neck cancer or surgical or radiation treatment to the head and neck region
  • Patients taking medication that might effect their swallowing function
  • Patients with gastroenterologic dysfunction
  • Patients who have previously undergone swallowing therapy
  • Patients with cognitive impairments that limit their ability to follow and comply with multi-step commands

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Swallowing Exercise Group
Swallowing Exercise Group: This arm will undergo the protocol that involves intensive swallowing exercises to begin at the start of the cancer treatment. Those patients randomized to the intensive therapy protocol will be required to participate in weekly swallowing therapy sessions either in person or over the phone and perform the learned swallowing exercises three times a day. In addition, these patients will document their swallowing practice on a daily basis.
Behavioral: Swallowing Exercise Group

Swallowing Exercises

Perform each exercise 10 times. Do these 3 times a day. Vary the order of the exercises.

Effortful Swallow: As you swallow squeeze hard with all your muscles. (Can do with water or without)

Super Supraglottic Swallow:

Inhale and hold your breath very tightly, bearing down. Keep holding your breath and bearing down as you swallow. Cough when you are finished. (Can do with water or without)

Tongue Hold Maneuver:

Gently hold your tongue in between your front teeth and swallow your saliva.

Tongue Retraction:

Pull the back of your tongue to the back of your mouth and hold.

Mendelsohn Maneuver:

Swallow your saliva and pay attention to your neck as you swallow. Try to feel that something (your Adam's apple of voice box) lifts and lowers as you swallow. Now, when you swallow and you feel something lift as you swallow don't let it drop. Hold it with your muscles for several seconds.

Other Names:
  • Prophylactic Swallowing Exercises
No Intervention: Control
Control Arm: This arm will receive the standard of care which provides swallowing evaluation and treatment once symptoms of swallowing dysfunction are experienced by the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
Time Frame: This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
Time Frame: This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
Time Frame: This will be completed at 3 months post treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
This will be completed at 3 months post treatment. Participants will be followed for up to 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
Time Frame: This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
Time Frame: This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
Time Frame: This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment.
Functional Oral Intake Scale (FOIS)
Time Frame: This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.
Functional Oral Intake Scale (FOIS)
Time Frame: This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment.
Functional Oral Intake Scale (FOIS)
Time Frame: This will be completed at 3 post treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
This will be completed at 3 post treatment. Participants will be followed for up to 24 months after treatment.
Functional Oral Intake Scale (FOIS)
Time Frame: This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment.
Functional Oral Intake Scale (FOIS)
Time Frame: This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment.
Functional Oral Intake Scale (FOIS)
Time Frame: This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Tamar Kotz, MS, CCC, SLP, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

February 28, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (Estimate)

May 6, 2011

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO # 07-0462

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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