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

NCT ID: NCT01766349

Last Updated: 2015-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-09-30

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.

Detailed Description

Background and Purpose: Incidence rates of esophageal cancer vary internationally with the higher rate found in Eastern Asia. Preoperative concurrent chemoradiation therapy (CCRT) for resectable esophageal cancer has been shown to improve overall survival in meta-analyses. Preoperative pulmonary function and functional capacity are known predictive factors for the development of postoperative pulmonary complications in patient undergoing major cancer surgery. Little is known concerning the impacts of preoperative CCRT on pulmonary function and functional capacity in patients with esophageal cancer. The aim of this study is to examine changes of respiratory performance and functional exercise capacity during RT or CCRT, the relations between these changes, and the impacts of these changes on the postoperative outcomes in patients with esophageal cancer.

Method: Patients with newly diagnosed esophageal cancer without metastasis will be recruited from the Far Eastern Memorial Hospital. Demographic data will be obtained from the chart. Respiratory muscle strength will be measured by maximal inspiratory and expiratory pressure. Spirometric variables will be tested by force expiratory volume in one second and forced vital capacity. Dyspnea will be measured using modified Borg scale. Functional exercise capacity will be measured by six minute walk distance. Quality of life will be measured using EORTC QOL-C30 and QOL-OES18 instruments. All the measurements will be repeated weekly during the concurrent therapy period. Repeated measure ANOVA will be used for analyzing difference among various time points. Spearman correlation coefficient will be used to test relationship between multiple variables. For patients who are receiving esophagectomy after CCRT or RT, pulmonary complications and total length of hospital stay will be documented.

Clinical relevance: The results of this study will help to better understand the indications for chest physiotherapy (e.g., respiratory muscle weakness, reduced functional capacity, and their related sequels)

Conditions

Esophageal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

esophagus cancer patients

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

respiratory muscle performance

Intervention Type: BEHAVIORAL

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

Interventions

respiratory muscle performance

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• primary esophagus cancer
• planning to receive radiation therapy

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chen-Hsi Hsieh, MD., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, Far Eastern Memorial Hospital

Locations

Far Eastern Memorial hospital

New Taipei City, , Taiwan

Countries

Taiwan

Other Identifiers

FEMH-IRB-100066-E

Identifier Type: -

Identifier Source: org_study_id