Clinical Trials Logo

Clinical Trial Summary

This randomized clinical trial studies how well expiratory muscle strength training works in improving bulbar function and quality of life in patients with head and neck cancer. Expiratory muscle strength training may help to strengthen the muscles involved in breathing and swallowing and may allow improved breathing, airway safety, swallow function, and quality of life in patients with head and neck cancer.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. Investigate the impact of a prophylactic targeted exercise program, expiratory muscle strength training (EMST), on swallowing function and well-being of individuals on head and neck cancer (HNC).

II. Determine the impact of EMST on objective respiratory measures of individuals with HNC.

III. Determine the relationship between mean dose across the swallowing muscles (oral tongue and supra-hyoids, base of tongue, superior, middle and inferior pharyngeal constrictors, proximal esophagus)/dose on each muscle and the swallowing functional outcomes from aim 1.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients also perform prescribed exercises at home daily for 3 sets of 10 repetitions.

ARM II: Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients perform prescribed exercises at home daily for 3 sets of 10 repetitions. Patients also participate in an EMST session over 30 minutes comprising of 5 sets of 5 repetitions daily for 5 days per week for 6 weeks during chemoradiation therapy.

After completion of study, patients are followed up at 1, 3, 6, and 12 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03175289
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Completed
Phase N/A
Start date September 29, 2016
Completion date January 3, 2019

See also
  Status Clinical Trial Phase
Completed NCT01896778 - Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer N/A
Completed NCT02960308 - Whole-Neck Computed Tomography Perfusion Scan in Imaging Patients With Head and Neck Tumors
Active, not recruiting NCT05126797 - 3D Printed Oral Stents for Patients With Head and Neck Cancer Receiving Radiation Therapy N/A
Active, not recruiting NCT04607590 - Yoga Program for Improving the Quality of Life in Couples Coping With Cancer
Recruiting NCT01365169 - Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients" N/A
Active, not recruiting NCT05036330 - ProvoxLife Adoption Trends for Heat-Moisture Exchanger
Completed NCT03032250 - Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer N/A
Completed NCT04456140 - Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study Phase 1
Active, not recruiting NCT01366144 - Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction Phase 1
Completed NCT02480114 - Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy Phase 3
Recruiting NCT05457478 - The Use of "Smart" Body-Weight Scales for Weight and Nutritional Monitoring in Patients With Head and Neck Cancer Undergoing Radiation Therapy N/A
Recruiting NCT05108233 - Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course
Recruiting NCT04963972 - Digital and Behavioral Tele-Health Tapering Program for Lowering Dependence on Opioids in Patients Undergoing Surgery N/A
Completed NCT05793957 - Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms N/A