Clinical trial NCT01349309: The Effect of Prophylactic Swallowing Exercises on Head and Neck Cancer Patients
Official title: The Effect of Prophylactic Swallowing Exercises on Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: Prophylactic Swallowing Exercises
Head and Neck Cancer
Dysphagia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2011-05-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
timeFrame: This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.
measure: Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
timeFrame: This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment.
measure: Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
timeFrame: This will be completed at 3 months post treatment. Participants will be followed for up to 24 months after treatment.
measure: Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
timeFrame: This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment.
measure: Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
timeFrame: This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment.
measure: Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
timeFrame: This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment.
measure: Functional Oral Intake Scale (FOIS)
timeFrame: This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.
measure: Functional Oral Intake Scale (FOIS)
timeFrame: This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment.
measure: Functional Oral Intake Scale (FOIS)
timeFrame: This will be completed at 3 post treatment. Participants will be followed for up to 24 months after treatment.
measure: Functional Oral Intake Scale (FOIS)
timeFrame: This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment.
measure: Functional Oral Intake Scale (FOIS)
timeFrame: This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment.
measure: Functional Oral Intake Scale (FOIS)
timeFrame: This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Tamar Kotz, MS, CCC, SLP
role: PRINCIPAL_INVESTIGATOR
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