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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099629
• Other study ID #: 13MMHIS300
• Status: Completed
• Phase: N/A
• First received: March 14, 2017
• Last updated: March 31, 2017
• Start date: March 2015
• Est. completion date: October 2016

Study information

• Verified date: March 2017
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Respiratory Aspiration

Intervention

Behavioral:
• inspiratory muscle training
inspiratory muscle training 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.

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of maximal inspiratory pressure (MIP)	Change from baseline MIP at the end of each week's CCRT treatment	Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Primary	Changes of maximal expiratory pressure (MEP)	Change from baseline MEP at the end of each week's CCRT treatment	Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Primary	Changes of diaphragmatic surface electromyography (EMGdi)	Change from baseline EMGdi at the end of each week's CCRT treatment	Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Primary	Changes of forced expiratory volume in one second (FEV1)	Change from baseline FEV1 at the end of each week's CCRT treatment	Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Primary	Changes of forced vital capacity (FVC)	Change from baseline FVC at the end of each week's CCRT treatment	Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Secondary	Changes of functional exercise capacity using 6-minute walking distance	Change from baseline 6-minute walking distance at the end of each week's CCRT treatment	Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Secondary	Changes of dyspnea using Modified Borg Dyspnea score	Change from baseline Modified Borg Dyspnea score at the end of each week's CCRT treatment	Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)