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

April 18, 2017 updated by: Yu-Jen Chen, Mackay Memorial Hospital
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • MacKay Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

newly diagnosed primary esophageal cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, weekly during 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
Baseline, weekly during 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
Baseline, weekly during treatment, and 2 weeks after the completion of treatment
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
Baseline, weekly during treatment, and 2 weeks after the completion of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of functional exercise capacity
Time Frame: 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
Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Change of dyspnea
Time Frame: 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
Baseline, weekly during treatment, and 2 weeks after the completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

April 18, 2017

First Posted (ACTUAL)

April 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11MMHIS183

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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