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Trial registered on ANZCTR


Registration number
ACTRN12624000820505
Ethics application status
Approved
Date submitted
5/06/2024
Date registered
3/07/2024
Date last updated
3/07/2024
Date data sharing statement initially provided
3/07/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a single bout of exercise and chronic training program on cancer cells in breast cancer survivors
Scientific title
Acute and chronic exercise effects on myokine expression and cancer suppression in breast cancer survivors
Secondary ID [1] 312295 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 334026 0
Condition category
Condition code
Cancer 330698 330698 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Firstly, participants will be randomly allocated, using a digital software, to aerobic or resistance training group.
After one week of familiarization where participants will be guided to the exercise training session with an accredited exercise physiologist, participants will perform a single bout of resistance training at moderate to high intensity for approximately 60 minutes under supervision of accredited exercise physiologist, 1 to 1 in the gym (acute session 1). Intensity will be measured using rating perceived of exertion 0-10, % of repetition maximum. For the resistance training, machine-based exercises including chest press, leg press, seated row, leg curl, push press, leg extension, pull down, lunges will be used.
One week after, participants will commence a 12-week of resistance training, 3 times per week for 60 minutes, with an intensity ranging from moderate to high, under supervision of accredited exercise physiologist in small groups in the gym (3 to 4 participants) (chronic intervention). Intensity will be measured using rating perceived of exertion 0-10, % of repetition maximum. Adherence will be monitored using a checklist. For the resistance training, machine-based exercises including chest press, leg press, seated row, leg curl, push press, leg extension, pull down, lunges will be used.
Lastly, one week after the conclusion of the 12-week of training program, participants will perform another single bout of resistance training at moderate to high intensity for approximately 60 minutes under supervision of accredited exercise physiologist 1 to 1 in the gym (acute session 2). Intensity will be measured using rating perceived of exertion 0-10, % of repetition maximum. For the resistance training, machine-based exercises including chest press, leg press, seated row, leg curl, push press, leg extension, pull down, lunges will be used.
Intervention code [1] 328757 0
Treatment: Other
Comparator / control treatment
Firstly, participants will be randomly allocated, using a digital software, to aerobic or resistance training group.
After one week of familiarization where participants will be guided to the exercise training session with an accredited exercise physiologist, participants will perform a single bout of aerobic training at moderate to high intensity for approximately 60 minutes under supervision of accredited exercise physiologist, 1 to 1 in the gym (acute session 1). Intensity will be measured using heart rate maximum. For the aerobic training, bicycle, treadmill, rower and cross-trainer will be used.
One week after, participants will commence a 12-week aerobic training, 3 times per week for 60 minutes, with an intensity ranging from moderate to high, under supervision of accredited exercise physiologist in small groups in the gym (3 to 4 participants) (chronic intervention). Intensity will be measured using heart rate maximum. Adherence will be monitored using a checklist. For the aerobic training, bicycle, treadmill, rower and cross-trainer will be used.
Lastly, one week after the conclusion of the 12-week of training program, participants will perform another single bout of aerobic training at moderate to high intensity for approximately 60 minutes under supervision of accredited exercise physiologist 1 to 1 in the gym (acute session 2). Intensity will be measured using heart rate maximum. For the aerobic training, bicycle, treadmill, rower and cross-trainer will be used.
Control group
Active

Outcomes
Primary outcome [1] 338448 0
Cell growth rate of breast cancer cell lines will be assessed
Timepoint [1] 338448 0
Before and after the single bout of exercise (single study session before the chronic training program), before and after 12 weeks of chronic training program, and before and after the single bout of exercise (single study session after the chronic training program)
Primary outcome [2] 338608 0
Serum myokines of interleukin 6 (IL-6) will be measured
Timepoint [2] 338608 0
Before and after the single bout of exercise (single study session before the chronic training program), before and after 12 weeks of chronic training program, and before and after the single bout of exercise (single study session after the chronic training program)
Primary outcome [3] 338689 0
Serum myokines of decorin will be measured
Timepoint [3] 338689 0
Before and after the single bout of exercise (single study session before the chronic training program), before and after 12 weeks of chronic training program, and before and after the single bout of exercise (single study session after the chronic training program)
Secondary outcome [1] 435976 0
Changes in body weight and body composition will be assessed (this will be assessed as a composite outcome)
Timepoint [1] 435976 0
Before and after the chronic training program
Secondary outcome [2] 436587 0
Maximal strength
Timepoint [2] 436587 0
Before and after the chronic training program
Secondary outcome [3] 436588 0
Maximum Volume of Oxygen (VO2max)
Timepoint [3] 436588 0
Before and after the chronic training program
Secondary outcome [4] 436589 0
Quality of life
Timepoint [4] 436589 0
Before and after the chronic training program
Secondary outcome [5] 437034 0
Serum myokines of oncostatin m (OSM) will be measured
Timepoint [5] 437034 0
Before and after the single bout of exercise (single study session before the chronic training program), before and after 12 weeks of chronic training program, and before and after the single bout of exercise (single study session after the chronic training program)
Secondary outcome [6] 437035 0
Serum myokines of secreted protein acidic and rich in cysteine (SPARC) will be measured
Timepoint [6] 437035 0
Before and after the single bout of exercise (single study session before the chronic training program), before and after 12 weeks of chronic training program, and before and after the single bout of exercise (single study session after the chronic training program)

Eligibility
Key inclusion criteria
To be included in the current study, subjects have to meet the following inclusion criteria: 1) women with stage I-III breast cancer; 2) with or without endocrine therapy; 3) completed primary treatment (e.g., chemotherapy, radiation therapy, surgery) at least 4 months prior; 4) BMI between 18.5 and 35 kg/m2; 5) medically cleared for exercise; and 6) willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
Minimum age
18 Years
Maximum age
74 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are: 1) any known absolute contraindication to exercise; 2) currently completing vigorous exercise in the past 3 months (i.e., Aerobic training more than 150 or 75 minutes at moderate or high intensity respectively, or resistance training more than 2 sessions per week at moderate to high intensity); 3) life expectancy less than 12 months; and 4) pregnant or lactating. Additionally, subjects will be required to maintain their habitual diet throughout the training program.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All data will be analysed using SPSS (version 25.0; SPSS, Inc., Armonk, NY). Normality will be analysed using the Shapiro-Wilk test. Studies 1 and 3, acute exercise sessions: Repeated measures ANOVA (or Freidman’s ANOVA for data not normally distributed) will be used to calculate within-group differences in myokine expression and cancer cell growth and proliferation from pre- to post-intervention, while group x time repeated measures ANOVA will be used to calculate between-group differences (data not normally distributed will be log transformed). Study 2, chronic training intervention: For baseline comparisons, independent t-tests or the Mann-Whitney U test will be used for continuous data, as appropriate, and Chi-square for categorical variables. Group x time repeated measures ANOVA or ANCOVA (with log transformation for data not normally distributed) will be used to calculate between-group intervention effects on myokines, cancer cell growth and proliferation, body weight and body composition, maximal strength, VO2max and QoL questionnaires, while paired samples t-tests or the Wilcoxon signed-rank test, as appropriate, will be used for within-group changes. Pearson or Spearman rank correlation analysis will be used to calculate the association between changes in body composition parameters and myokine levels. Tests will be two-tailed, and a p-value of 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/10/2023
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
30
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316682 0
University
Name [1] 316682 0
Edith Cowan University
Country [1] 316682 0
Australia
Primary sponsor type
University
Name
Edith cowan university
Address
Country
Australia
Secondary sponsor category [1] 318873 0
Individual
Name [1] 318873 0
Francesco Bettariga - Edith Cowan University
Address [1] 318873 0
Country [1] 318873 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315460 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 315460 0
Ethics committee country [1] 315460 0
Australia
Date submitted for ethics approval [1] 315460 0
28/07/2023
Approval date [1] 315460 0
29/09/2023
Ethics approval number [1] 315460 0
2023-04617-BETTARIGA

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

Contacts
Principal investigator
Name 134774 0
Mr Francesco Bettariga
Address 134774 0
Francesco Bettariga, Edith Cowan University, Prilep Dr, Joondalup WA 6027
Country 134774 0
Australia
Phone 134774 0
+61 411758131
Fax 134774 0
Email 134774 0
f.bettariga@ecu.edu.au
Contact person for public queries
Name 134775 0
Francesco Bettariga
Address 134775 0
Francesco Bettariga, Edith Cowan University, Prilep Dr, Joondalup WA 6027
Country 134775 0
Australia
Phone 134775 0
+61 411758131
Fax 134775 0
Email 134775 0
f.bettariga@ecu.edu.au
Contact person for scientific queries
Name 134776 0
Francesco Bettariga
Address 134776 0
Francesco Bettariga, Edith Cowan University, Prilep Dr, Joondalup WA 6027
Country 134776 0
Australia
Phone 134776 0
+61 411758131
Fax 134776 0
Email 134776 0
f.bettariga@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Findings regarding primary, secondary, and tertiary outcomes
When will data be available (start and end dates)?
From 1/05/2025 to 1/05/2035
Available to whom?
Researchers upon reasonable request
Available for what types of analyses?
IPD for meta-analysis, secondary analysis, protocol study.
How or where can data be obtained?
Emailing principal investigator f.bettariga@ecu.edu.au


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.