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Completed

NCT Number: NCT03120572

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

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mackay Memorial Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 19, 2017
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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