Effect of CCRT on Respiratory Performance and Functional Capacity in Esophagus Cancer Patients

NCT01766349 | Completed

• 1 other identifier: FEMH-IRB-100066-E
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are to investigate in patients with newly diagnosed esophageal cancer: 1)changes in pulmonary and respiratory muscle function, functional capacity and quality of life during and after RT or CCRT treatment; 2)the correlations between these changes; and 3)the impacts of these changes on the postoperative pulmonary complications following esophagectomy.

Conditions

Esophageal Cancer

Keywords

Esophageal cancer; Respiratory muscle strength; Pulmonary function testing; Functional exercise capacity

Outcome Measures

Primary Outcomes (1)

• Changes of respiratory muscle performance (MIP/MEP, PFT)from baseline

  Maximum inspiratory pressure (MIP) Maximum expiratory pressure (MEP) PFT: FEV1, FVC, FEV1/FVC

  Baseline, during CCRT or RT treatment (Day 5, Day 10, Day 15, Day 20, Day 25), 2 weeks after the completion of the treatment, 1 day pre-operation, and 1 month after operation

Secondary Outcomes (3)

• Changes of functional exercise capacity, dyspnea, and quality of life from baseline

  Baseline, during CCRT or RT treatment (Day 5, Day 10, Day 15, Day 20, Day 25), 2 weeks after the completion of the treatment, 1 day pre-operation, and 1 month after operation

• Prevalence of pulmonary complications

  During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)

• Total length of hospital stay

  During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)

Study Arms (1)

esophagus cancer patients

Respiratory muscle performance will be followed in patients with esophagus cancer during CCRT or RT treatments.

Behavioral: respiratory muscle performance

Interventions

respiratory muscle performance BEHAVIORAL

Respiratory muscle performance will include measurements of respiratory muscle strength and pulmonary function testing.

esophagus cancer patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with primary esophagus cancer and receive radiation therapy

You may qualify if:

• primary esophagus cancer
• planning to receive radiation therapy

You may not qualify if:

• MMSE \< 24
• A clinical diagnosis affecting respiratory muscle function and functional activity performance
• Unstable angina or acute myocardial infarction prior 1 month of assessment

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Chen-Hsi Hsieh, MD., Ph.D.

  Department of Radiation Oncology, Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 11, 2013
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 5, 2015

Record last verified: 2013-01

Locations

TW (1)