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

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ClinicalTrials.gov Identifier: NCT03099629
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Yu-Jen Chen, Mackay Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Behavioral: inspiratory muscle training Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Inspiratory Muscle Training on Respiratory Performance in Patients With Esophageal Cancer Receiving Combined Modality Therapy
Actual Study Start Date : March 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IMT
inspiratory muscle training
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. Changes of functional exercise capacity using 6-minute walking distance [ Time Frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks) ]
    Change from baseline 6-minute walking distance at the end of each week's CCRT treatment

  2. Changes of dyspnea using Modified Borg Dyspnea score [ Time Frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks) ]
    Change from baseline Modified Borg Dyspnea score at the end of each week's CCRT 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
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.

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): NCT03099629


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: NCT03099629     History of Changes
Other Study ID Numbers: 13MMHIS300
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017

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

Additional relevant MeSH terms:
Esophageal Neoplasms
Respiratory Aspiration
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes