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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120572
• Other study ID #: 11MMHIS183
• Status: Completed
• Phase: N/A
• First received: March 14, 2017
• Last updated: April 18, 2017
• Start date: August 2013
• Est. completion date: February 2016

Study information

• Verified date: April 2017
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of maximal inspiratory pressure (MIP)	Change from baseline MIP at the end of each week's treatment, and 2 weeks after the completion of treatment	Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Primary	Change of diaphragmatic surface electromyography (EMGdi)	Change from baseline EMGdi at the end of each week's treatment, and 2 weeks after the completion of treatment	Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Primary	Change of forced expiratory volume in one second (FEV1)	Change from baseline FEV1 at the end of each week's treatment, and 2 weeks after the completion of treatment	Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Primary	Change of forced vital capacity (FVC)	Change from baseline FVC at the end of each week's treatment, and 2 weeks after the completion of treatment	Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Secondary	Change of functional exercise capacity	Change from baseline 6-minute walking distance at the end of each week's treatment, and 2 weeks after the completion of treatment	Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Secondary	Change of dyspnea	Change from baseline Modified Borg Dyspnea score at the end of each week's treatment, and 2 weeks after the completion of treatment	Baseline, weekly during treatment, and 2 weeks after the completion of treatment