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

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ClinicalTrials.gov Identifier: NCT03120572
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Yu-Jen Chen, 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.

Condition or disease
Esophageal 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 Type : Observational [Patient Registry]
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Local Esophagus Cancer
Study Start Date : August 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
newly diagnosed primary esophageal cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120572


Locations
Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
Mackay Memorial Hospital

Responsible Party: Yu-Jen Chen, VS. Division of Radiation Oncology, Department of Radiology, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT03120572     History of Changes
Other Study ID Numbers: 11MMHIS183
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017

Keywords provided by Yu-Jen Chen, Mackay Memorial Hospital:
Respiratory muscle strength
Diaphragmatic surface electromyography
Functional capacity

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases