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Trial registered on ANZCTR


Registration number
ACTRN12621001601820
Ethics application status
Approved
Date submitted
15/09/2021
Date registered
24/11/2021
Date last updated
24/11/2021
Date data sharing statement initially provided
24/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The PREVENT study: Does PRE-habilitation improVe pErformance status in uN-resectable stage III non-small cell lung cancer (NSCLC) patients undergoing chemo-radioTherapy? - A pilot study
Scientific title
The PREVENT study: Does PRE-habilitation improVe pErformance status in uN-resectable stage III NSCLC patients undergoing chemo-radioTherapy? - A pilot study
Secondary ID [1] 304884 0
None
Universal Trial Number (UTN)
U1111-1268-2485
Trial acronym
The PREVENT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with un-resectable stage III non-small cell lung cancer (NSCLC) undergoing chemo-radiotherapy. 323011 0
Condition category
Condition code
Cancer 320573 320573 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sessions will be individual and face-to-face, which will be held at the physiotherapy clinic at the Ballarat Regional Integrated Cancer Centre (BRICC) or Queen Elizabeth Centre. Each 50-minute mixed exercise session will consist of:
- 5-minute warm-up on stationary bike at self-selected pace.
- 20 minutes of aerobic exercise (i.e., treadmill jogging/running and cycling).
- 10 minutes of resistance exercise (e.g., bench press, leg press, etc.).
- 10 minutes of structured, assisted stretching (i.e., upper body and lower body stretches).
- 5-minute cool down.

The length of the intervention will last the duration of the patient's chemo-radiation therapy, which will be for a minimum of at least 3 weeks and up to a maximum of 8 weeks. Training progression will be in consecutive 2-week epochs with increasing intensity determined by participant’s individual heart rate maximum (HRM):
- Weeks 1 and 2: 2 x 50 minutes (up to 55% HRM)
- Weeks 3 and 4: 3 x 50 minutes (up to 60% HRM)
- Weeks 5 and 6: 3 x 50 minutes (up to 65% HRM)
- Weeks 7 and 8: 3 x 50 minutes (up to 70% HRM)

Adherence to the intervention will be monitored using a session attendance checklist, and individual programming will be guided by proprietary software [goXpro, Sydney, AU (https://www.goxpro.com/optin-454228331608376497106)].
Intervention code [1] 321278 0
Treatment: Other
Intervention code [2] 321881 0
Lifestyle
Comparator / control treatment
Patients in the control group will undergo standard care without any exercise intervention, as per Ballarat Regional Integrated Cancer Centre (BRICC) protocol and recommended by their lung cancer specialist(s).
Control group
Active

Outcomes
Primary outcome [1] 328394 0
Aerobic fitness will be determined by peak oxygen consumption (VO2peak), which will be estimated using a submaximal cardio-pulmonary exercise test (CPET) performed on an electronically braked cycle ergometer as per guidelines published by the American Heart Association (Balady et al., 2010).
Timepoint [1] 328394 0
Baseline and 8-weeks post-intervention commencement.
Primary outcome [2] 328395 0
Functional capacity will be assessed using the 6-minute walk test (6MWT), following the guidelines set out by American Thoracic Society (2002).
Timepoint [2] 328395 0
Baseline and 8-weeks post-intervention commencement.
Secondary outcome [1] 398886 0
Pulmonary function will be determined by the patient’s forced expiratory volume in the first second (FEV1). Patients will be required to undergo a spirometry test.
Timepoint [1] 398886 0
Baseline and 8-weeks post-intervention commencement.
Secondary outcome [2] 398889 0
The Eastern Cooperative Oncology Group (ECOG) Performance Status instrument will used to assess how a patient’s disease is progressing and how the disease is affecting the daily living abilities of the patient.
Timepoint [2] 398889 0
Baseline and 8-weeks post-intervention commencement.
Secondary outcome [3] 398890 0
Cancer-specific quality of life (QoL) will be measured using the Functional Assessment of Cancer Therapy-Lung (FACT-L) instrument (version 4). The FACT-L is a 36-item self-reported questionnaire designed to measure multidimensional QoL over the previous 7 days for patients diagnosed with lung cancer.
Timepoint [3] 398890 0
Baseline and 8-weeks post-intervention commencement.
Secondary outcome [4] 398894 0
Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983). The HADS is a 14-item self-reported questionnaire developed to assess psychological stress in non-psychiatric patients.
Timepoint [4] 398894 0
Baseline and 8-weeks post-intervention commencement.
Secondary outcome [5] 398896 0
Adverse events will be defined as any side effect from the intervention (exercise-related adverse events), side effect from the patient’s cancer treatment (treatment-related adverse events), or side effect from the cancer itself (cancer-related adverse events). These will be reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE; version 5.0) criteria. Information on adverse events will include the type of adverse event, a description of the event, the time and data of the event, and any other relevant information.
Timepoint [5] 398896 0
Baseline and 8-weeks post-intervention commencement.

Eligibility
Key inclusion criteria
1. Male/female participants, who are at least 18 years of age on the day of signing informed consent with previously untreated, pathologically confirmed NSCLC and Stage IIIA, IIIB or IIIC NSCLC by American Joint Committee on Cancer Version 8.
2. No evidence of metastatic disease by whole body PET/CT scan, diagnostic quality CT scan, and brain imaging
3. Have un-resectable disease, that is amenable to be treated with radical-intent chemo-radiotherapy, as decided through a thoracic multidisciplinary meeting.
4. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
5. Have adequate pulmonary function test (PFT) as a forced expiratory volume in 1 second (FEV1) >50% of predicted normal volume and the carbon monoxide lung diffusing capacity (DLCO) >40% of predicted normal value.
6. Fulfill the guideline requirements in the APSS.
7. Have capacity to provide written informed consent for the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A women of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to treatment allocation.
2. Has small cell lung cancer. Mixed tumours will be categorized by the predominant cell type: if small cell elements are present, the participant is ineligible.
3. Has had documented weight loss >10% in the preceding 3 months.
4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation will be delivered in a sealed opaque envelope to each patient to conceal allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random sequence generator will be used to allocate patients to one of the two groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A total of 20 patients is considered viable for this pilot trial. It is important to note that the main purpose of this pilot trial is to confirm the safety and feasibility of exercise as a prehabilitation adjunct for NSCLC patients, and thus, the statistical differences between outcome variables can be considered a secondary purpose. Data will be analysed using STATA/SE statistical package (version 15.1; StataCorp, 2017). Demographic variables will be reported using means (M), standard deviations (SDs), and odds ratios (ORs). T-tests and analysis of variance (ANOVA) will be used to statistically compare the experimental and control groups on quantitative outcomes. Safety and feasibility outcomes will be descriptively reported, and quantitative analysis will be performed if appropriate. The significance level will be set at p < .05 for all analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2022
Actual
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20083 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment postcode(s) [1] 34791 0
3350 - Ballarat Central

Funding & Sponsors
Funding source category [1] 309257 0
Hospital
Name [1] 309257 0
Ballarat Health Services
Country [1] 309257 0
Australia
Primary sponsor type
Hospital
Name
Ballarat Health Services (Base Hospital) - Ballarat Central
Address
1 Drummond Street North, Ballarat Central, VIC, 3350
Country
Australia
Secondary sponsor category [1] 310231 0
University
Name [1] 310231 0
Federation University Australia
Address [1] 310231 0
Office of Deputy Vice Chancellor of Research and Innovation, University Drive, Mount Helen, VIC, 3350
Country [1] 310231 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309101 0
Ballarat Health Services and St John of God Healthcare Human Research Ethics Committee
Ethics committee address [1] 309101 0
Ethics committee country [1] 309101 0
Australia
Date submitted for ethics approval [1] 309101 0
09/04/2021
Approval date [1] 309101 0
07/09/2021
Ethics approval number [1] 309101 0
75148

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112978 0
Dr Wasek Faisal
Address 112978 0
Ballarat Regional Integrated Cancer Centre (BRICC), 1 Drummond Street North, Ballarat Central, VIC, 3350
Country 112978 0
Australia
Phone 112978 0
+61 3 5320 8796
Fax 112978 0
Email 112978 0
wasek.faisal@bhs.org.au
Contact person for public queries
Name 112979 0
Wasek Faisal
Address 112979 0
Ballarat Regional Integrated Cancer Centre (BRICC), 1 Drummond Street North, Ballarat Central, VIC, 3350
Country 112979 0
Australia
Phone 112979 0
+61 3 5320 8796
Fax 112979 0
Email 112979 0
wasek.faisal@bhs.org.au
Contact person for scientific queries
Name 112980 0
Wasek Faisal
Address 112980 0
Ballarat Regional Integrated Cancer Centre (BRICC), 1 Drummond Street North, Ballarat Central, VIC, 3350
Country 112980 0
Australia
Phone 112980 0
+61 3 5320 8796
Fax 112980 0
Email 112980 0
wasek.faisal@bhs.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
Individual participant data will not be publicly available in order to maintain anonymity of patients and their personal data.


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.