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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
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Scientific title
Acute and chronic exercise effects on myokine expression and cancer suppression in breast cancer survivors
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Secondary ID [1]
312295
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast cancer
334026
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Condition category
Condition code
Cancer
330698
330698
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0
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Breast
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328757
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Cell growth rate of breast cancer cell lines will be assessed
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Assessment method [1]
338448
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Real time cell analysis (RTCA) system and E-plate using serum sample
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Timepoint [1]
338448
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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)
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Primary outcome [2]
338608
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Serum myokines of interleukin 6 (IL-6) will be measured
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Assessment method [2]
338608
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Enzyme-Linked Immunosorbent Assay (ELISA Kit) using serum sample
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Timepoint [2]
338608
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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)
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Primary outcome [3]
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Serum myokines of decorin will be measured
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Assessment method [3]
338689
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Enzyme-Linked Immunosorbent Assay (ELISA Kit) using serum sample
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Timepoint [3]
338689
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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)
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Secondary outcome [1]
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Changes in body weight and body composition will be assessed (this will be assessed as a composite outcome)
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Assessment method [1]
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Dual-Energy X-ray Absorptiometry (DXA) to measure body weight and body composition
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Timepoint [1]
435976
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Before and after the chronic training program
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Secondary outcome [2]
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Maximal strength
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Assessment method [2]
436587
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1-repetition maximum test for chest press and leg press
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Timepoint [2]
436587
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Before and after the chronic training program
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Secondary outcome [3]
436588
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Maximum Volume of Oxygen (VO2max)
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Assessment method [3]
436588
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Ekblom Bak test
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Timepoint [3]
436588
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Before and after the chronic training program
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Secondary outcome [4]
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Quality of life
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Assessment method [4]
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European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Breast Cancer Module 45
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Timepoint [4]
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Before and after the chronic training program
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Secondary outcome [5]
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Serum myokines of oncostatin m (OSM) will be measured
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Assessment method [5]
437034
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Enzyme-Linked Immunosorbent Assay (ELISA Kit) using serum sample
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Timepoint [5]
437034
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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)
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Secondary outcome [6]
437035
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Serum myokines of secreted protein acidic and rich in cysteine (SPARC) will be measured
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Assessment method [6]
437035
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Enzyme-Linked Immunosorbent Assay (ELISA Kit) using serum sample
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Timepoint [6]
437035
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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)
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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.
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Minimum age
18
Years
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Maximum age
74
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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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)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
2/10/2023
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Date of last participant enrolment
Anticipated
30/08/2024
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Actual
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Date of last data collection
Anticipated
1/05/2025
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Actual
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Sample size
Target
30
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Accrual to date
15
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
316682
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University
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Name [1]
316682
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Edith Cowan University
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Address [1]
316682
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Country [1]
316682
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Australia
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Primary sponsor type
University
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Name
Edith cowan university
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Address
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Country
Australia
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Secondary sponsor category [1]
318873
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Individual
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Name [1]
318873
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Francesco Bettariga - Edith Cowan University
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Address [1]
318873
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Country [1]
318873
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315460
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Edith Cowan University Human Research Ethics Committee
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Ethics committee address [1]
315460
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http://www.ecu.edu.au/GPPS/ethics
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Ethics committee country [1]
315460
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Australia
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Date submitted for ethics approval [1]
315460
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28/07/2023
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Approval date [1]
315460
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29/09/2023
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Ethics approval number [1]
315460
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2023-04617-BETTARIGA
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Summary
Brief summary
The aim of this project is to explore the effects of an acute bout of exercise (before and after a training intervention) and the chronic effects of a 12-week resistance vs aerobic training program on acute and resting expression of signalling proteins, known as myokines, and their cancer-suppressive effects, in relation to body composition, in breast cancer survivors. Who is it for? You may be eligible for this study if you are a woman with stage I-III breast cancer who has completed primary treatment at least 4 months prior to commencing this trial, and have been medically cleared for exercise. Study details Participants will be randomly allocated to a 12-week exercise program involving either resistance or aerobic training. In the weeks immediately before and after the 12-week program, participants will also complete an acute bout of exercise. Participants will be asked to provide blood and complete questionnaires and physical testing before and after the acute bouts of exercise and 12-week program. It is hoped that findings from this study shed light into the mechanisms behind exercise's effect on breast cancer management.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Francesco Bettariga
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Address
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Francesco Bettariga, Edith Cowan University, Prilep Dr, Joondalup WA 6027
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Country
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Australia
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Phone
134774
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+61 411758131
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Fax
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Email
134774
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[email protected]
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Contact person for public queries
Name
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Francesco Bettariga
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Address
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Francesco Bettariga, Edith Cowan University, Prilep Dr, Joondalup WA 6027
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Country
134775
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Australia
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Phone
134775
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+61 411758131
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Fax
134775
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Email
134775
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[email protected]
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Contact person for scientific queries
Name
134776
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Francesco Bettariga
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Address
134776
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Francesco Bettariga, Edith Cowan University, Prilep Dr, Joondalup WA 6027
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Country
134776
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Australia
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Phone
134776
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+61 411758131
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Fax
134776
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Email
134776
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Findings regarding primary, secondary, and tertiary outcomes
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When will data be available (start and end dates)?
From 1/05/2025 to 1/05/2035
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Available to whom?
Researchers upon reasonable request
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Available for what types of analyses?
IPD for meta-analysis, secondary analysis, protocol study.
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How or where can data be obtained?
Emailing principal investigator
[email protected]
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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.
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