Effects of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
Summary
RATIONALE: Swallowing exercise therapy may improve the quality of life of head and neck cancer patients undergoing chemotherapy or radiation therapy.
PURPOSE: This randomized phase III trial is studying early onset of swallowing exercise therapy to see how well it works compared to late onset of swallowing exercise therapy in treating patients with head and neck cancer undergoing chemotherapy or radiation therapy.
Description
PRIMARY OBJECTIVE:
I. To assess the difference between early and late onset swallowing exercises on swallowing quality of life in patients undergoing chemo/radiation therapy for head and neck cancer.
SECONDARY OBJECTIVE:
I. To assess the difference between early and late onset swallowing exercises on swallowing function in patients undergoing radiation therapy for head and neck cancer.
TERTIARY OBJECTIVE:
I. To assess the difference between early and late onset swallowing exercises on: individual domains of swallowing quality of life; Penetration Aspiration Scale (PAS) as assessed via FEES; diet level (Dysphagia Outcome and Severity Scale (DOSS) as assessed via FEES; feeding tube duration (days); Eating Assessment Tool (EAT); lingual strength as assessed via lingual manometry; and percent weight loss and percent weight recovery.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I (Early exercise group): Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.
Arm II (Late exercise group): Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
In both arms, swallowing exercises are performed twice daily, 6 days a week, for 12 months following completion of radiotherapy.
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Conditions
Head and Neck Cancer
Intervention
exercise intervention, questionnaire administration, quality-of-life assessment
Location
Wake Forest University Health Sciences
Winston-Salem
North Carolina
United States
27157
Status
Not yet recruiting
Source
Wake Forest University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01053546
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:16:28-0400
Clinical Trials
Exercise in Improving Health and Quality of Life in Breast Cancer Survivors
This randomized pilot trial studies how well exercise works in improving health and quality of life in breast cancer survivors. Participating in an exercise program to maintain physical ac...
RATIONALE: Collecting information by questionnaire about the quality of life of patients with head and neck cancer may help doctors learn more about the disease. PURPOSE: This clinical tr...
RATIONALE: Developing a questionnaire that patients can use to assess their quality of life related to the appearance of their face after surgery may help doctors plan the best treatment f...
This clinical trial studies how well the sensorimotor rehabilitation program works in improving quality of life in patients with early stage breast cancer. A hand and foot sensory improvem...
Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors
RATIONALE: A breast cancer rehabilitation program and exercise therapy may help improve the quality of life of breast cancer survivors. PURPOSE: This clinical trial studies a breast canc...
PubMed Articles
Head and neck cancer: validation of the QLQ-H&N35 quality of life questionnaire.
Head and neck cancer affects esthetic and anatomical parameters, causing pain and functional impotence, affecting vital functions such as eating and breathing, hampering the quality of life of patient...
The development of heart disease, followed by the pacemaker implantation, has reduced the quality and psychological problems for patients. Thus, the present study was conducted to determine the effect...
A better understanding of coeliac disease can be achieved by assessing health-related quality of life alongside clinical factors. Existing patient-reported outcome measures (PROMs) evaluating quality ...
Head and neck cancer treatment affects quality of life. There are differences in quality of life outcomes and perceived supportive care needs between cancer patients living in metropolitan and regiona...
To conduct a descriptive analysis of the results from the Functional Assessment of Cancer Therapy-General (FACT-G) quality of life (QOL) questionnaire, describe the outcomes from the FACT-G to drive t...
Medical and Biotech [MESH] Definitions
Exercise Test
Controlled physical activity, more strenuous than at rest, which is performed in order to allow assessment of physiological functions, particularly cardiovascular and pulmonary, but also aerobic capacity. Maximal (most intense) exercise is usually required but submaximal exercise is also used. The intensity of exercise is often graded, using criteria such as rate of work done, oxygen consumption, and heart rate.
Quality-adjusted Life Years
A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)
Quality Assurance, Health Care
Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.
Quality Of Life
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.
Sickness Impact Profile
A quality-of-life scale developed in the United States in 1972 as a measure of health status or dysfunction generated by a disease. It is a behaviorally based questionnaire for patients and addresses activities such as sleep and rest, mobility, recreation, home management, emotional behavior, social interaction, and the like. It measures the patient's perceived health status and is sensitive enough to detect changes or differences in health status occurring over time or between groups. (From Medical Care, vol.xix, no.8, August 1981, p.787-805)
