Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03120572
Enrollment
45
Registered
2017-04-19
Start date
2013-08-31
Completion date
2016-02-29
Last updated
2017-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Respiratory muscle strength, Diaphragmatic surface electromyography, Functional capacity

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.

Interventions

None listed

Sponsors

Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change of maximal inspiratory pressure (MIP)Baseline, weekly during treatment, and 2 weeks after the completion of treatmentChange 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)Baseline, weekly during treatment, and 2 weeks after the completion of treatmentChange 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)Baseline, weekly during treatment, and 2 weeks after the completion of treatmentChange from baseline FEV1 at the end of each week's treatment, and 2 weeks after the completion of treatment
Change of forced vital capacity (FVC)Baseline, weekly during treatment, and 2 weeks after the completion of treatmentChange from baseline FVC at the end of each week's treatment, and 2 weeks after the completion of treatment

Secondary

MeasureTime frameDescription
Change of functional exercise capacityBaseline, weekly during treatment, and 2 weeks after the completion of treatmentChange from baseline 6-minute walking distance at the end of each week's treatment, and 2 weeks after the completion of treatment
Change of dyspneaBaseline, weekly during treatment, and 2 weeks after the completion of treatmentChange from baseline Modified Borg Dyspnea score at the end of each week's treatment, and 2 weeks after the completion of treatment

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026