NCT03834116

Brief Summary

A small-scale pilot randomized controlled trial conducted by the investigators demonstrated some preliminary evidence that inspiratory muscle training (IMT) could be a promising self-management method for alleviating breathlessness. Hence, the aim of this study is to assess the effectiveness of IMT in patients with thoracic malignancies on dyspnea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

February 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

November 23, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

February 1, 2019

Last Update Submit

August 22, 2022

Conditions

Lung Neoplasm Malignant

Outcome Measures

Primary Outcomes (1)

  • Modified Borg Scale (mBorg)

    It is a vertical 0-10 scale, with corresponding verbal expressions of progressively increased intensity from "nothing at all" to ''maximal."

    week 8

Secondary Outcomes (12)

  • 6-minute walk test (6MWT)

    week 8

  • 6-minute walk test (6MWT)

    week 12

  • Dyspnea Symptoms and Its Impact on Patients' Functional Status (Dyspnea-12 Questionnaire).

    Week 8

  • Dyspnea Symptoms and Its Impact on Patients' Functional Status (Dyspnea-12 Questionnaire).

    Week 12

  • Perceived Severity of Breathlessness

    week 8

  • +7 more secondary outcomes

Study Arms (2)

Inspiratory muscle training group

EXPERIMENTAL

A pressure threshold device will be used to deliver IMT, which is commercially available by Phillips Respironics.

Device: Inspiratory muscle training

Control group

NO INTERVENTION

The control group will receive standard treatment in a fast-track design.

Interventions

Inspiratory muscle trainingDEVICE

A pressure threshold device will be used to deliver IMT, which is commercially available by Phillips Respironics.

Inspiratory muscle training group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adults with histological diagnosis of primary LC or mesothelioma;
  • refractory dyspnea not responding to current treatment for the past 2 weeks;
  • expected prognosis of \>3 months as judged by the clinicians,
  • oxygen saturation above 85% at rest.

You may not qualify if:

  • Those with unstable COPD with frequent or acute exacerbations,
  • rapidly worsening dyspnea requiring urgent medical intervention,
  • treatment with palliative radiotherapy to the chest received within 4 weeks or chemotherapy within 2 weeks;
  • experiencing intractable cough, and those having unstable angina or clinically significant pleural effusion needing drainage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Medical University Hospital

Luzhou, China

Location

Related Publications (9)

  • Barton R, English A, Nabb S, Rigby AS, Johnson MJ. A randomised trial of high vs low intensity training in breathing techniques for breathless patients with malignant lung disease: a feasibility study. Lung Cancer. 2010 Dec;70(3):313-9. doi: 10.1016/j.lungcan.2010.03.007. Epub 2010 Apr 14.

    PMID: 20392515BACKGROUND

  • Molassiotis A, Charalambous A, Taylor P, Stamataki Z, Summers Y. The effect of resistance inspiratory muscle training in the management of breathlessness in patients with thoracic malignancies: a feasibility randomised trial. Support Care Cancer. 2015 Jun;23(6):1637-45. doi: 10.1007/s00520-014-2511-x. Epub 2014 Nov 23.

    PMID: 25417042BACKGROUND

  • Farquhar MC, Higginson IJ, Fagan P, Booth S. The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease. BMC Palliat Care. 2009 Jul 7;8:9. doi: 10.1186/1472-684X-8-9.

    PMID: 19583857BACKGROUND

  • Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J (Clin Res Ed). 1982 May 29;284(6329):1607-8. doi: 10.1136/bmj.284.6329.1607. No abstract available.

    PMID: 6805625BACKGROUND

  • Tan JY, Yorke J, Harle A, Smith J, Blackhall F, Pilling M, Molassiotis A. Assessment of Breathlessness in Lung Cancer: Psychometric Properties of the Dyspnea-12 Questionnaire. J Pain Symptom Manage. 2017 Feb;53(2):208-215. doi: 10.1016/j.jpainsymman.2016.08.009. Epub 2016 Oct 5.

    PMID: 27720789BACKGROUND

  • Wilcock A, Crosby V, Clarke D, Tattersfield A. Repeatability of breathlessness measurements in cancer patients. Thorax. 1999 Apr;54(4):375. doi: 10.1136/thx.54.4.374b. No abstract available.

    PMID: 10400541BACKGROUND

  • Xu W, Collet JP, Shapiro S, Lin Y, Yang T, Wang C, Bourbeau J. Validation and clinical interpretation of the St George's Respiratory Questionnaire among COPD patients, China. Int J Tuberc Lung Dis. 2009 Feb;13(2):181-9.

    PMID: 19146745BACKGROUND

  • Walker J, Postma K, McHugh GS, Rush R, Coyle B, Strong V, Sharpe M. Performance of the Hospital Anxiety and Depression Scale as a screening tool for major depressive disorder in cancer patients. J Psychosom Res. 2007 Jul;63(1):83-91. doi: 10.1016/j.jpsychores.2007.01.009.

    PMID: 17586341BACKGROUND

  • Li MY, Liu XL, Peng B, Wang T, Yao LQ, Huang HQ, Kwok WH, Tan JB, Molassiotis A. The effect of resistance inspiratory muscle training in the management of breathlessness in patients with thoracic malignancies: a randomised controlled trial. Support Care Cancer. 2025 May 22;33(6):492. doi: 10.1007/s00520-025-09511-9.

    PMID: 40402333DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Alex Molassiotis

    The Hong Kong Polytechnic University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor of Nursing and Head

Study Record Dates

First Submitted

February 1, 2019

First Posted

February 7, 2019

Study Start

November 23, 2019

Primary Completion

September 15, 2021

Study Completion

September 15, 2021

Last Updated

August 23, 2022

Record last verified: 2022-08

Locations

CN(1)