Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Local Esophagus Cancer

Completed

• Conditions: Esophageal Cancer

• Registration Number: NCT03120572
• Lead Sponsor: Mackay Memorial Hospital

Brief Summary

The purpose of this study is to investigate the effect of concurrent chemoradiation therapy on respiratory muscle performance, lung function and functional capacity in patients with local esophagus cancer.

Detailed Description

This is a prospective observational study design. A total of 45 patients with newly diagnosed esophageal cancer will be recruited from the Mackay Memorial Hospital. All tests will be performed at baseline (prior to cancer treatment), weekly during treatment, prior to surgery, and one month after surgery. Tests will include demographic data collection, respiratory muscle performance (maximal inspiratory and expiratory pressure tests combined with diaphragmatic surface electromyography, and pulmonary functional test), dyspnea, and the functional exercise test (6-min walk test).Repeated measure ANOVA will be used for analyzing difference of parameters among various time points.

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2017-03-14
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Study First Posted: 2017-04-19
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• newly diagnosed primary esophageal cancer, aged more than 20 years, and communicate without difficulty

Exclusion Criteria

• inability to perform inspiratory muscle training, the presence of unstable angina or myocardial infarction in recently one month, cannot cooperate with training protocols, and pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of forced vital capacity (FVC)	Baseline, weekly during treatment, and 2 weeks after the completion of treatment	Change from baseline FVC at the end of each week's treatment, and 2 weeks after the completion of treatment
Change of maximal inspiratory pressure (MIP)	Baseline, weekly during treatment, and 2 weeks after the completion of treatment	Change from baseline MIP at the end of each week's treatment, and 2 weeks after the completion of treatment
Change of diaphragmatic surface electromyography (EMGdi)	Baseline, weekly during treatment, and 2 weeks after the completion of treatment	Change from baseline EMGdi at the end of each week's treatment, and 2 weeks after the completion of treatment
Change of forced expiratory volume in one second (FEV1)	Baseline, weekly during treatment, and 2 weeks after the completion of treatment	Change from baseline FEV1 at the end of each week's treatment, and 2 weeks after the completion of treatment

Secondary Outcome Measures

Name	Time	Method
Change of functional exercise capacity	Baseline, weekly during treatment, and 2 weeks after the completion of treatment	Change from baseline 6-minute walking distance at the end of each week's treatment, and 2 weeks after the completion of treatment
Change of dyspnea	Baseline, weekly during treatment, and 2 weeks after the completion of treatment	Change from baseline Modified Borg Dyspnea score at the end of each week's treatment, and 2 weeks after the completion of treatment

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan