Clinical trial NCT01766349: Effect of CCRT on Respiratory Performance and Functional Capacity in Esophagus Cancer Patients
Official title: Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Primary Esophagus Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: Esophageal cancer
Respiratory muscle strength
Pulmonary function testing
Functional exercise capacity
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with primary esophagus cancer and receive radiation therapy

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)

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

Primary outcomes:
measure: Changes of respiratory muscle performance (MIP/MEP, PFT)from baseline
timeFrame: 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:
measure: Changes of functional exercise capacity, dyspnea, and quality of life from baseline
timeFrame: 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
measure: Prevalence of pulmonary complications
timeFrame: During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
measure: Total length of hospital stay
timeFrame: During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial hospital
Study officials:
affiliation: Department of Radiation Oncology, Far Eastern Memorial Hospital
name: Chen-Hsi Hsieh, MD., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: