Esophageal CancerNCT03099629
Efficacy of Inspiratory Muscle Training on Respiratory Performance in Patients With Esophageal Cancer Receiving Combined Modality Therapy
A study testing inspiratory muscle training in people with Esophageal Cancer, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the effectiveness of inspiratory muscle training (IMT) on respiratory performance in patients with esophageal cancer during combined modality therapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- inspiratory muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2015to Oct 2016
- Phase
- Interventional
- 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
Who may be able to join
- newly diagnosed primary esophageal cancer, aged more than 20 years, 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 effectiveness of inspiratory muscle training (IMT) on respiratory performance in patients with esophageal cancer during combined modality therapy.
Read the detailed description
Background and Purpose: Incidence rates of esophageal cancer remain high in Eastern Asia. In 2012, esophageal cancer was the 9th leading cause of cancer deaths in Taiwan. Whether surgical resection is possible, combined modality therapy is usually required for the treatment of esophageal cancer. In clinical observation, patients underwent combined modality therapy usually demonstrated respiratory muscle dysfunction which might further impair physical activity and quality of life. The purpose of this study is to investigate the effectiveness of inspiratory muscle training (IMT) on respiratory performance in patients with esophageal cancer during combined modality therapy.
Methods: This is a prospective interventional 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). IMT will start with an intensity of 30% of maximal inspiratory pressure, 15 times/set, 3 sets/day, 7 days/week and training will continue until surgery is scheduled or 2 weeks after the completion of treatment if surgery is not suitable. Repeated measure ANOVA will be used for analyzing difference of parameters among various time points.
Clinical relevance: The results of this study will help to better understand the clinical beneficial effects (e.g., better functional capacity) of an added inspiratory muscle training during combined modality therapy in patients with esophageal cancer.
- Conditions
- Esophageal Cancer
- Being tested
- inspiratory muscle training
- Keywords
- Inspiratory muscle training, Diaphragmatic surface electromyography, Respiratory muscle strength, Functional 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.
inspiratory muscle trainingBehavioural
inspiratory muscle training will start with an intensity of 30% of maximal inspiratory pressure, 15 times/set, 3 sets/day, 7 days/week and training will continue until surgery is scheduled or 2 weeks after the completion of treatment if surgery is not suitable.
| Study group | Role | What they receive |
|---|---|---|
| IMT | Experimental | inspiratory muscle training Receives: Behavioral: inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of maximal inspiratory pressure (MIP)
Change from baseline MIP at the end of each week's CCRT treatment
Measured: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Changes of maximal expiratory pressure (MEP)
Change from baseline MEP at the end of each week's CCRT treatment
Measured: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Changes of diaphragmatic surface electromyography (EMGdi)
Change from baseline EMGdi at the end of each week's CCRT treatment
Measured: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Changes of forced expiratory volume in one second (FEV1)
Change from baseline FEV1 at the end of each week's CCRT treatment
Measured: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Changes of forced vital capacity (FVC)
Change from baseline FVC at the end of each week's CCRT treatment
Measured: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Secondary outcomes (2)
Changes of functional exercise capacity using 6-minute walking distance
Change from baseline 6-minute walking distance at the end of each week's CCRT treatment
Measured: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Changes of dyspnea using Modified Borg Dyspnea score
Change from baseline Modified Borg Dyspnea score at the end of each week's CCRT treatment
Measured: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startMar 2015
- Primary completionMay 2016
- Study completionOct 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
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
- NCT03099629
- Sponsor's protocol ID
- 13MMHIS300
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Inspiratory Muscle Training on Respiratory Performance in Patients With Esophageal Cancer Receiving Combined Modality Therapy
- ClinicalTrials.gov ID
- NCT03099629
- Acronym / sponsor ID
- 13MMHIS300
- Conditions
- Esophageal Cancer
- Keywords
- Inspiratory muscle training, Diaphragmatic surface electromyography, Respiratory muscle strength, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 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 effectiveness of inspiratory muscle training (IMT) on respiratory performance in patients with esophageal cancer during combined modality therapy.
Detailed description
Background and Purpose: Incidence rates of esophageal cancer remain high in Eastern Asia. In 2012, esophageal cancer was the 9th leading cause of cancer deaths in Taiwan. Whether surgical resection is possible, combined modality therapy is usually required for the treatment of esophageal cancer. In clinical observation, patients underwent combined modality therapy usually demonstrated respiratory muscle dysfunction which might further impair physical activity and quality of life. The purpose of this study is to investigate the effectiveness of inspiratory muscle training (IMT) on respiratory performance in patients with esophageal cancer during combined modality therapy.
Methods: This is a prospective interventional 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). IMT will start with an intensity of 30% of maximal inspiratory pressure, 15 times/set, 3 sets/day, 7 days/week and training will continue until surgery is scheduled or 2 weeks after the completion of treatment if surgery is not suitable. Repeated measure ANOVA will be used for analyzing difference of parameters among various time points.
Clinical relevance: The results of this study will help to better understand the clinical beneficial effects (e.g., better functional capacity) of an added inspiratory muscle training during combined modality therapy in patients with esophageal cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMT | Experimental | Behavioral: inspiratory muscle traininginspiratory muscle training |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- newly diagnosed primary esophageal cancer, aged more than 20 years, 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory muscle traininginspiratory muscle training will start with an intensity of 30% of maximal inspiratory pressure, 15 times/set, 3 sets/day, 7 days/week and training will continue until surgery is scheduled or 2 weeks after the completion of treatment if surgery is not suitable. | Behavioural | IMT |
Primary outcome
Changes of maximal inspiratory pressure (MIP)
Time frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Change from baseline MIP at the end of each week's CCRT treatment
Changes of maximal expiratory pressure (MEP)
Time frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Change from baseline MEP at the end of each week's CCRT treatment
Changes of diaphragmatic surface electromyography (EMGdi)
Time frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Change from baseline EMGdi at the end of each week's CCRT treatment
Changes of forced expiratory volume in one second (FEV1)
Time frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Change from baseline FEV1 at the end of each week's CCRT treatment
Changes of forced vital capacity (FVC)
Time frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Change from baseline FVC at the end of each week's CCRT treatment
2 secondary outcomes
Changes of functional exercise capacity using 6-minute walking distance
Time frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Changes of dyspnea using Modified Borg Dyspnea score
Time frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
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 4 Apr 2017.
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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?
A study testing inspiratory muscle training in people with 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 4 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?
Changes of maximal inspiratory pressure (MIP) (time frame: Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)). The study lists 5 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 4 Apr 2017.