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Completed

NCT Number: NCT01766349

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Far Eastern Memorial hospital

New Taipei City, Taiwan

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

respiratory muscle performance

Behavioral

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

Primary outcomes

  1. 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

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

Secondary outcomes

  1. 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

    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.

  2. Prevalence of pulmonary complications

    Time frame: During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)

    Data will be retrieved from the chart.

  3. Total length of hospital stay

    Time frame: During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)

    Data will be retrieved from the chart.

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2013
Registry last updated
Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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