Effect of CCRT on Respiratory Performance and Functional Capacity in Esophagus Cancer Patients
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Primary Esophagus Cancer|
- Changes of respiratory muscle performance (MIP/MEP, PFT)from baseline [ 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 ] [ Designated as safety issue: No ]Maximum inspiratory pressure (MIP) Maximum expiratory pressure (MEP) PFT: FEV1, FVC, FEV1/FVC
- Changes of functional exercise capacity, dyspnea, and quality of life from baseline [ 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 ] [ Designated as safety issue: No ]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.
- Prevalence of pulmonary complications [ Time Frame: During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months) ] [ Designated as safety issue: No ]Data will be retrieved from the chart.
- Total length of hospital stay [ Time Frame: During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months) ] [ Designated as safety issue: No ]Data will be retrieved from the chart.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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.
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766349
|Contact: Chen-Hsi Hsieh, M.D., Ph.D.||firstname.lastname@example.org|
|Far Eastern Memorial hospital||Recruiting|
|New Taipei City, Taiwan|
|Contact: Chen-Hsi Hsieh, MD, Ph.D. 7728-2152 email@example.com|
|Principal Investigator:||Chen-Hsi Hsieh, MD., Ph.D.||Department of Radiation Oncology, Far Eastern Memorial Hospital|