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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Mount Sinai School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01349309
First received: February 28, 2011
Last updated: November 4, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Dysphagia
Behavioral: Prophylactic Swallowing Exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Prophylactic Swallowing Exercises on Head and Neck Cancer Patients

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    A seven point scale of diet tolerance.

  • 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. ] [ Designated as safety issue: No ]
    A seven point scale of diet tolerance.

  • 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. ] [ Designated as safety issue: No ]
    A seven point scale of diet tolerance.

  • 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. ] [ Designated as safety issue: No ]
    A seven point scale of diet tolerance.

  • 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. ] [ Designated as safety issue: No ]
    A seven point scale of diet tolerance.

  • 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. ] [ Designated as safety issue: No ]
    A seven point scale of diet tolerance.


Enrollment: 26
Study Start Date: June 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Prophylactic Swallowing Exercises

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.

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349309

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Tamar Kotz, MS, CCC, SLP Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01349309     History of Changes
Other Study ID Numbers: GCO # 07-0462
Study First Received: February 28, 2011
Last Updated: November 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Prophylactic Swallowing Exercises
Head and Neck Cancer
Dysphagia

Additional relevant MeSH terms:
Deglutition Disorders
Head and Neck Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014