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

18 Years
80 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

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

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)

Inclusion Criteria:

- primary esophagus cancer

- planning to receive radiation therapy

Exclusion Criteria:

- MMSE < 24

- A clinical diagnosis affecting respiratory muscle function and functional activity

- Unstable angina or acute myocardial infarction prior 1 month of assessment

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiation Oncology, Far Eastern Memorial Hospital


Taiwan: Institutional Review Board

Study ID:




Start Date:

September 2011

Completion Date:

September 2013

Related Keywords:

  • Esophageal Cancer
  • Esophageal cancer
  • Respiratory muscle strength
  • Pulmonary function testing
  • Functional exercise capacity
  • Esophageal Diseases
  • Esophageal Neoplasms