Skip to main content
Clinical Trials/NCT03099629
NCT03099629
Completed
Not Applicable

Efficacy of Inspiratory Muscle Training on Respiratory Performance in Patients With Esophageal Cancer Receiving Combined Modality Therapy

Mackay Memorial Hospital1 site in 1 country6 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
Mackay Memorial Hospital
Enrollment
6
Locations
1
Primary Endpoint
Changes of diaphragmatic surface electromyography (EMGdi)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to investigate the effectiveness of inspiratory muscle training (IMT) on respiratory performance in patients with esophageal cancer during combined modality therapy.

Detailed Description

Background and Purpose: Incidence rates of esophageal cancer remain high in Eastern Asia. In 2012, esophageal cancer was the 9th leading cause of cancer deaths in Taiwan. Whether surgical resection is possible, combined modality therapy is usually required for the treatment of esophageal cancer. In clinical observation, patients underwent combined modality therapy usually demonstrated respiratory muscle dysfunction which might further impair physical activity and quality of life. The purpose of this study is to investigate the effectiveness of inspiratory muscle training (IMT) on respiratory performance in patients with esophageal cancer during combined modality therapy. Methods: This is a prospective interventional 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). IMT will start with an intensity of 30% of maximal inspiratory pressure, 15 times/set, 3 sets/day, 7 days/week and training will continue until surgery is scheduled or 2 weeks after the completion of treatment if surgery is not suitable. Repeated measure ANOVA will be used for analyzing difference of parameters among various time points. Clinical relevance: The results of this study will help to better understand the clinical beneficial effects (e.g., better functional capacity) of an added inspiratory muscle training during combined modality therapy in patients with esophageal cancer.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
October 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yu-Jen Chen

VS. Division of Radiation Oncology, Department of Radiology

Mackay Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • newly diagnosed primary esophageal cancer, aged more than 20 years, 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.

Outcomes

Primary Outcomes

Changes of diaphragmatic surface electromyography (EMGdi)

Time Frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)

Change from baseline EMGdi at the end of each week's CCRT treatment

Changes of forced vital capacity (FVC)

Time Frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)

Change from baseline FVC at the end of each week's CCRT treatment

Changes of maximal inspiratory pressure (MIP)

Time Frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)

Change from baseline MIP at the end of each week's CCRT treatment

Changes of maximal expiratory pressure (MEP)

Time Frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)

Change from baseline MEP at the end of each week's CCRT treatment

Changes of forced expiratory volume in one second (FEV1)

Time Frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)

Change from baseline FEV1 at the end of each week's CCRT treatment

Secondary Outcomes

  • Changes of dyspnea using Modified Borg Dyspnea score(Baseline and weekly during CCRT treatment (for a total of 4-5 weeks))
  • Changes of functional exercise capacity using 6-minute walking distance(Baseline and weekly during CCRT treatment (for a total of 4-5 weeks))

Study Sites (1)

Loading locations...

Similar Trials