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

Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Primary Esophagus Cancer

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Behavioral: respiratory muscle performance

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)

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Far Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with primary esophagus cancer and receive radiation therapy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
esophagus cancer patients; Respiratory muscle performance will be followed in patients with esophagus cancer during CCRT or RT treatments.	Behavioral: respiratory muscle performance; Respiratory muscle performance will include measurements of respiratory muscle strength and pulmonary function testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of functional exercise capacity, dyspnea, and quality of life from baseline	Functional exercise capacity will be measured using six-minute walk test. Modified Borg scale will be used to measure dyspnea. EORTC QOL-C30 and QOL-OES18 instruments will be used to measure Quality of life.	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	Data will be retrieved from the chart.	During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
Total length of hospital stay	Data will be retrieved from the chart.	During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Investigators: Principal Investigator: Chen-Hsi Hsieh, MD., Ph.D., Department of Radiation Oncology, Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: January 9, 2013
• First Posted (Estimate): January 11, 2013

Study Record Updates

• Last Update Posted (Estimate): February 5, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Esophageal cancer; Pulmonary function testing; Functional exercise capacity; Respiratory muscle strength
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: FEMH-IRB-100066-E