NCT03099629

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

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

March 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

March 14, 2017

Last Update Submit

March 31, 2017

Conditions

Esophageal Cancer

Keywords

Inspiratory muscle trainingDiaphragmatic surface electromyographyRespiratory muscle strengthFunctional capacity

Outcome Measures

Primary Outcomes (5)

  • Changes of maximal inspiratory pressure (MIP)

    Change from baseline MIP at the end of each week's CCRT treatment

    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

    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

    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

    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

    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

    Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)

  • Changes of dyspnea using Modified Borg Dyspnea score

    Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)

Study Arms (1)

IMT

EXPERIMENTAL

inspiratory muscle training

Behavioral: inspiratory muscle training

Interventions

inspiratory muscle trainingBEHAVIORAL

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.

IMT

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed primary esophageal cancer, aged more than 20 years, 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
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
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 4, 2017

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Study Completion

October 1, 2016

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

TW(1)