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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Far Eastern Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01766349
First received: December 20, 2012
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Esophageal Cancer
Behavioral: respiratory muscle performance

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
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)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with primary esophagus cancer and receive radiation therapy

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766349

Contacts
Contact: Chen-Hsi Hsieh, M.D., Ph.D. chenciab@gmail.com

Locations
Taiwan
Far Eastern Memorial hospital Recruiting
New Taipei City, Taiwan
Contact: Chen-Hsi Hsieh, MD, Ph.D.    7728-2152    chenciab@gmail.com   
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Chen-Hsi Hsieh, MD., Ph.D. Department of Radiation Oncology, Far Eastern Memorial Hospital
  More Information

No publications provided

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01766349     History of Changes
Other Study ID Numbers: FEMH-IRB-100066-E
Study First Received: December 20, 2012
Last Updated: January 10, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Far Eastern Memorial Hospital:
Esophageal cancer
Respiratory muscle strength
Pulmonary function testing
Functional exercise capacity

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 26, 2014