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Completed

NCT Number: NCT01349309

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

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swallowing Exercise Group

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 6, 2011
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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