Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000359538
Ethics application status
Approved
Date submitted
17/01/2024
Date registered
28/03/2024
Date last updated
28/03/2024
Date data sharing statement initially provided
28/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Long term outcomes of those undergoing lung cancer surgery.
Scientific title
Change in long term physical function following lung cancer surgery.
Secondary ID [1] 310972 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 332058 0
Condition category
Condition code
Cancer 328782 328782 0 0
Lung - Non small cell
Cancer 328783 328783 0 0
Lung - Small cell
Cancer 329530 329530 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
People undergoing lung cancer surgery will complete two study visits (one pre-operatively, between two-four weeks prior to surgery, and the second six months post-operatively.)

At each study visit the participants will undergo lung function testing (spirometry, lung volumes, diffusion capacity and oscillometry) as well as incremental shuttle walk testing with portable cardiopulmonary exercise testing equipment insitu.
Additionally, during the first study visit, participants will have a V/Q SPECT performed to calculate lung ventilation.
Visit 1 will be in clinic for around 2.5 hours and Visit 2 will be in clinic and take around 1.5 hours.
Intervention code [1] 327404 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336592 0
Change in exercise capacity, oxygen consumption and exertional dyspnoea from pre-operative to six month post-operative timepoint
Timepoint [1] 336592 0
Baseline and six months post-operatively
Primary outcome [2] 337325 0
Change in oxygen consumption from pre-operative to six month post-operative timepoint
Timepoint [2] 337325 0
Baseline and six months post-operatively
Primary outcome [3] 337326 0
Change in exertional dyspnoea from pre-operative to six month post-operative timepoint
Timepoint [3] 337326 0
Baseline and six months post-operatively
Secondary outcome [1] 428902 0
Change in lung function post-operatively
Timepoint [1] 428902 0
Baseline to six months post-operatively
Secondary outcome [2] 428903 0
Change in airway impedance
Timepoint [2] 428903 0
Baseline to six months post-operatively

Eligibility
Key inclusion criteria
Adults undergoing lung cancer resection surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling to participate
Unable to attend appointments prior to surgery

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
24/11/2025
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25843 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 41670 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 315230 0
Hospital
Name [1] 315230 0
Royal North Shore Hospital
Country [1] 315230 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Reserve Road, St Leonards, NSW, 2065
Country
Australia
Secondary sponsor category [1] 317262 0
None
Name [1] 317262 0
Address [1] 317262 0
Country [1] 317262 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314155 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 314155 0
Reserve Road, St Leonards, NSW, 2065
Ethics committee country [1] 314155 0
Australia
Date submitted for ethics approval [1] 314155 0
28/07/2023
Approval date [1] 314155 0
14/09/2023
Ethics approval number [1] 314155 0

Summary
Brief summary
The purpose of this study is to determine whether exercise capacity and lung function changes after lung cancer resection surgery, and whether there are any predictors for these changes.

Who is it for?
You may be eligible for this study if you are an adult with lung cancer that is scheduled to undergo lung cancer resection surgery.

Study details
All participants in this study will undergo their lung resection surgery as part of their standard care. For this study participants will be asked to attend two sessions at an outpatient hospital clinic to undergo physical exercise and lung function testing and complete a scan. This session will take approximately 2.5 hours and will occur within two-four weeks prior to surgery and again 6 months after surgery. The tests undertaken will be lung function testing, walk testing, symptom questionnaires and a ventilation/perfusion SPECT scan.

This study hopes to better understand changes in physical capacity and symptoms after lung cancer surgery and whether there are ways to predict those changes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130610 0
A/Prof Gregory King
Address 130610 0
Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country 130610 0
Australia
Phone 130610 0
+61 294632935
Fax 130610 0
Email 130610 0
ggk@woolcock.org.au
Contact person for public queries
Name 130611 0
A/Prof Gregory King
Address 130611 0
Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country 130611 0
Australia
Phone 130611 0
+61 294632935
Fax 130611 0
Email 130611 0
ggk@woolcock.org.au
Contact person for scientific queries
Name 130612 0
A/Prof Gregory King
Address 130612 0
Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country 130612 0
Australia
Phone 130612 0
+61 294632935
Fax 130612 0
Email 130612 0
ggk@woolcock.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.