Esophageal CancerNCT01766349
Effect of CCRT on Respiratory Performance and Functional Capacity in Esophagus Cancer Patients
An observational study of Esophageal Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- respiratory muscle performance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2011to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with primary esophagus cancer and receive radiation therapy
Who may be able to join
- primary esophagus cancer
- planning to receive radiation therapy
Who cannot join
- MMSE < 24
- A clinical diagnosis affecting respiratory muscle function and functional activity performance
- Unstable angina or acute myocardial infarction prior 1 month of assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Primary Esophagus Cancer
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.
Read the 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)
- Conditions
- Esophageal Cancer
- Being tested
- respiratory muscle performance
- Keywords
- Esophageal cancer, Respiratory muscle strength, Pulmonary function testing, Functional exercise capacity
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory muscle performanceBehavioural
Respiratory muscle performance will include measurements of respiratory muscle strength and pulmonary function testing.
| Study group | Role | What they receive |
|---|---|---|
| esophagus cancer patients | Respiratory muscle performance will be followed in patients with esophagus cancer during CCRT or RT treatments. Receives: Behavioral: respiratory muscle performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of respiratory muscle performance (MIP/MEP, PFT)from baseline
Maximum inspiratory pressure (MIP) Maximum expiratory pressure (MEP) PFT: FEV1, FVC, FEV1/FVC
Measured: 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 (3)
Changes of functional exercise capacity, dyspnea, and quality of life from baseline
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.
Measured: 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
Prevalence of pulmonary complications
Data will be retrieved from the chart.
Measured: During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
Total length of hospital stay
Data will be retrieved from the chart.
Measured: During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen-Hsi Hsieh, MD., Ph.D., Principal investigator, Department of Radiation Oncology, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766349
- Sponsor's protocol ID
- FEMH-IRB-100066-E
- Status last verified
- Jan 2013
- First submitted
- 20 Dec 2012
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Primary Esophagus Cancer
- ClinicalTrials.gov ID
- NCT01766349
- Acronym / sponsor ID
- FEMH-IRB-100066-E
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal cancer, Respiratory muscle strength, Pulmonary function testing, Functional exercise capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| esophagus cancer patients | – | Behavioral: respiratory muscle performanceRespiratory muscle performance will be followed in patients with esophagus cancer during CCRT or RT treatments. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with primary esophagus cancer and receive radiation therapy
Key inclusion criteria (2 listed)
- primary esophagus cancer
- planning to receive radiation therapy
Key exclusion criteria (3 listed)
- MMSE < 24
- A clinical diagnosis affecting respiratory muscle function and functional activity performance
- Unstable angina or acute myocardial infarction prior 1 month of assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| respiratory muscle performanceRespiratory muscle performance will include measurements of respiratory muscle strength and pulmonary function testing. | Behavioural | esophagus cancer patients |
Primary outcome
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
3 secondary outcomes
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
Prevalence of pulmonary complications
Time frame: During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
Total length of hospital stay
Time frame: During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen-Hsi Hsieh, MD., Ph.D. principal investigator
Department of Radiation Oncology, Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2015.