Esophageal CancerNCT03120572
Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Local Esophagus Cancer
An observational study of Esophageal Cancer, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the effect of concurrent chemoradiation therapy on respiratory muscle performance, lung function and functional capacity in patients with local esophagus cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Esophageal Cancer
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to Feb 2016
- How long will I take part?
- 2 Months
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: newly diagnosed primary esophageal cancer
Who may be able to join
- newly diagnosed primary esophageal cancer, aged more than 20 years, and communicate without difficulty
Who cannot join
- inability to perform inspiratory muscle training, the presence of unstable angina or myocardial infarction in recently one month, cannot cooperate with training protocols, and pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effect of concurrent chemoradiation therapy on respiratory muscle performance, lung function and functional capacity in patients with local esophagus cancer.
Read the detailed description
This is a prospective observational study design. A total of 45 patients with newly diagnosed esophageal cancer will be recruited from the Mackay Memorial Hospital. All tests will be performed at baseline (prior to cancer treatment), weekly during treatment, prior to surgery, and one month after surgery. Tests will include demographic data collection, respiratory muscle performance (maximal inspiratory and expiratory pressure tests combined with diaphragmatic surface electromyography, and pulmonary functional test), dyspnea, and the functional exercise test (6-min walk test).Repeated measure ANOVA will be used for analyzing difference of parameters among various time points.
- Conditions
- Esophageal Cancer
- Keywords
- Respiratory muscle strength, Diaphragmatic surface electromyography, Functional capacity
- Medical subject headings
- Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of maximal inspiratory pressure (MIP)
Change from baseline MIP at the end of each week's treatment, and 2 weeks after the completion of treatment
Measured: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Change of diaphragmatic surface electromyography (EMGdi)
Change from baseline EMGdi at the end of each week's treatment, and 2 weeks after the completion of treatment
Measured: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Change of forced expiratory volume in one second (FEV1)
Change from baseline FEV1 at the end of each week's treatment, and 2 weeks after the completion of treatment
Measured: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Change of forced vital capacity (FVC)
Change from baseline FVC at the end of each week's treatment, and 2 weeks after the completion of treatment
Measured: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Secondary outcomes (2)
Change of functional exercise capacity
Change from baseline 6-minute walking distance at the end of each week's treatment, and 2 weeks after the completion of treatment
Measured: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Change of dyspnea
Change from baseline Modified Borg Dyspnea score at the end of each week's treatment, and 2 weeks after the completion of treatment
Measured: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startAug 2013
- Primary completionFeb 2016
- Study completionFeb 2016
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
- 45 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Jen Chen, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120572
- Sponsor's protocol ID
- 11MMHIS183
- Status last verified
- Apr 2017
- First submitted
- 14 Mar 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. 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 Local Esophagus Cancer
- ClinicalTrials.gov ID
- NCT03120572
- Acronym / sponsor ID
- 11MMHIS183
- Conditions
- Esophageal Cancer
- Keywords
- Respiratory muscle strength, Diaphragmatic surface electromyography, Functional capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 Apr 2017 (actual)
- 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 purpose of this study is to investigate the effect of concurrent chemoradiation therapy on respiratory muscle performance, lung function and functional capacity in patients with local esophagus cancer.
Detailed description
This is a prospective observational study design. A total of 45 patients with newly diagnosed esophageal cancer will be recruited from the Mackay Memorial Hospital. All tests will be performed at baseline (prior to cancer treatment), weekly during treatment, prior to surgery, and one month after surgery. Tests will include demographic data collection, respiratory muscle performance (maximal inspiratory and expiratory pressure tests combined with diaphragmatic surface electromyography, and pulmonary functional test), dyspnea, and the functional exercise test (6-min walk test).Repeated measure ANOVA will be used for analyzing difference of parameters among various time points.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- newly diagnosed primary esophageal cancer
Key inclusion criteria (1 listed)
- newly diagnosed primary esophageal cancer, aged more than 20 years, and communicate without difficulty
Key exclusion criteria (1 listed)
- inability to perform inspiratory muscle training, the presence of unstable angina or myocardial infarction in recently one month, cannot cooperate with training protocols, and pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of maximal inspiratory pressure (MIP)
Time frame: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Change from baseline MIP at the end of each week's treatment, and 2 weeks after the completion of treatment
Change of diaphragmatic surface electromyography (EMGdi)
Time frame: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Change from baseline EMGdi at the end of each week's treatment, and 2 weeks after the completion of treatment
Change of forced expiratory volume in one second (FEV1)
Time frame: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Change from baseline FEV1 at the end of each week's treatment, and 2 weeks after the completion of treatment
Change of forced vital capacity (FVC)
Time frame: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Change from baseline FVC at the end of each week's treatment, and 2 weeks after the completion of treatment
2 secondary outcomes
Change of functional exercise capacity
Time frame: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Change of dyspnea
Time frame: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
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 19 Apr 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mackay 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 1 inclusion and 1 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 19 Apr 2017. 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?
Change of maximal inspiratory pressure (MIP) (time frame: Baseline, weekly during treatment, and 2 weeks after the completion of treatment). The study lists 4 primary outcomes in all. 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 19 Apr 2017.