Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Local Esophagus Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mackay Memorial Hospital
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change of forced vital capacity (FVC)
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change of forced vital capacity (FVC)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Change of functional exercise capacity(Baseline, weekly during treatment, and 2 weeks after the completion of treatment)
- Change of dyspnea(Baseline, weekly during treatment, and 2 weeks after the completion of treatment)
Investigators
Yu-Jen Chen
VS. Division of Radiation Oncology, Department of Radiology
Mackay Memorial Hospital