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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03120572
Other study ID # 11MMHIS183
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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