MedTrace Logo

Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients

NCT00796952 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2011-09-20

No results posted yet for this study

Summary

Swallowing dysfunction after chemo-radiation is common, but there is no reliable evidence for how it should be managed. This pilot randomized controlled trial evaluated the relative benefit of a battery of isometric / isotonic exercises on the maintenance of muscle composition and function for swallowing in Head / Neck Cancer patients undergoing chemo-radiation therapy.

Conditions

  • Head & Neck Cancer

Interventions

BEHAVIORAL

focused attention sessions

Patient management by the attending Radiation oncologist "as usual". Patients assigned to this condition received focused attention sessions during the total course of their CRT treatment from a Speech Language Pathologist, consisting of weekly phone calls to monitor their swallowing outcome during the radiotherapy period.

BEHAVIORAL

Valchuff

Standardised sham or placebo swallowing therapy comprised a buccal extension maneuver ("valchuff") and appropriate dietary modification, under the direction of the study speech pathologist, twice daily each week for the duration of the patient's total course of CRT treatment.

BEHAVIORAL

Pharyngocise

Standardized high intensity behavioral swallowing therapy (Pharyngocise) comprised a battery of direct isometric / isotonic exercises and appropriate dietary modification, under the direction of the study speech pathologist, twice daily for the duration of the patient's total course of their CRT treatment (up to a maximum of 6 weeks)

Sponsors & Collaborators

  • Florida Department of Health

    collaborator OTHER_GOV

  • University of Florida

    lead OTHER

Principal Investigators

  • Giselle Carnaby-Mann, PhD · University of Florida

  • Michael Crary, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2004-07-31
Completion
2005-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00796952 on ClinicalTrials.gov