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

Not Applicable

Completed

• Conditions: Dysphagia
• Interventions: Behavioral: Swallowing Exercise Group

• Registration Number: NCT01349309
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

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 Timeline

• Study Start: 2007-06
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-05-05
• Study First Posted: 2011-05-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Swallowing Exercise Group	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.

Primary Outcome Measures

Name	Time	Method
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).	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.
Functional Oral Intake Scale (FOIS)	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.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States