NCT03120572

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

2.5 years

First QC Date

March 14, 2017

Last Update Submit

April 18, 2017

Conditions

Esophageal Cancer

Keywords

Respiratory muscle strengthDiaphragmatic surface electromyographyFunctional capacity

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    Baseline, weekly during treatment, and 2 weeks after the completion of treatment

Secondary Outcomes (2)

  • Change of functional exercise capacity

    Baseline, weekly during treatment, and 2 weeks after the completion of treatment

  • Change of dyspnea

    Baseline, weekly during treatment, and 2 weeks after the completion of treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

newly diagnosed primary esophageal cancer

You may qualify if:

  • newly diagnosed primary esophageal cancer, aged more than 20 years, and communicate without difficulty

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
VS. Division of Radiation Oncology, Department of Radiology

Study Record Dates

First Submitted

March 14, 2017

First Posted

April 19, 2017

Study Start

August 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations

TW(1)