Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000698875
Ethics application status
Approved
Date submitted
22/02/2021
Date registered
7/06/2021
Date last updated
5/08/2022
Date data sharing statement initially provided
7/06/2021
Date results information initially provided
5/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a six-month high intensity interval training program on health outcomes in breast, prostate and colorectal cancer survivors.
Scientific title
The impact of high intensity interval training on the human gut microbiome of cancer survivors
Secondary ID [1] 303503 0
Nil known
Universal Trial Number (UTN)
U1111-1265-2204
Trial acronym
Linked study record
This record is a sub-study of ACTRN12618001855213.

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 320841 0
Prostate Cancer 320842 0
Colorectal Cancer 320843 0
Condition category
Condition code
Cancer 318664 318664 0 0
Breast
Cancer 318665 318665 0 0
Prostate
Cancer 318666 318666 0 0
Bowel - Anal
Cancer 318667 318667 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 318668 318668 0 0
Bowel - Small bowel (duodenum and ileum)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Controlled intervention will compare microbiome changes over six-months between cancer types. All participants will complete a four-week training program, supervised by an Accredited Exercise Physiologist or equivalent. This initial program will require attendance three times per week and entail a high-intensity interval training protocol of 4x4 minute intervals at 85-95% HRpeak, with three minute active recovery bouts between each interval. Attendance will be recorded in a supervised-training logbook. Similarly, adherence to 85-95% HRpeak during intervals will be recorded. This protocol requires a total of 38 minutes exercise and all exercise will be conducted on a cycle ergometer. The purpose of this period is to ensure all participants understand the exercise protocol and are able to complete it safely during the remainder of the study. Participants will then be provided with access to a facility with all required equipment available and encouraged to complete three sessions per week for the next six months. Participants will also be advised to maintain 150 minutes of moderate intensity or 75 minutes of vigorous intensity or a combination, therefore meeting the Australian exercise oncology guidelines. Participants will keep a log of the date and duration of exercise completed. Participants will be recruited from the Brisbane area, with the intervention being run from the University of Queensland and partnered gyms in the wider Brisbane area.
Intervention code [1] 319804 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326615 0
Human gut microbiome taxa abundance in stool samples assessed via 16S rRNA sequencing. This composite outcome will also provide representation of microbial diversity.
Timepoint [1] 326615 0
Participants will deposit a stool sample within the three days immediately prior to each testing occasion. Testing time-points will be at baseline (prior to supervised training), following the 4-weeks supervised training, and at three- and six-months (primary endpoint) following supervised training.
Secondary outcome [1] 392122 0
Cardiorespiratory fitness measured using a VO2peak test on a cycle ergometer (Lode Recumbent). Participants will progressively cycle to volitional fatigue, with breath by breath analysis using ParvoMedics TrueOne system.
Timepoint [1] 392122 0
Baseline, following supervised training (i.e. week 5), and at three- and six months following supervised training.
Secondary outcome [2] 392123 0
Body composition assessed using a DXA scan. A full body scan will be used to assess bone density, body fat percentage and muscle mass. Additionally, a left hip and lumbar spine scan will be done to further assess bone density. These results will be assessed in combination (composite)
Timepoint [2] 392123 0
Baseline, following supervised training (i.e. week 5), and at three- and six months following supervised training.
Secondary outcome [3] 392124 0
Blood biomarkers assessed using blood sampling. The specific outcomes are not determined as it will take an exploratory approach. It is expected that inflammatory markers (i.e. IGF-1, IGF-2, IGFBP3, IL-6 and IL-8); cholesterol (i.e. cholesterol and lipids), and relevant cancer-specific markers will be assessed.
Timepoint [3] 392124 0
Baseline, following supervised training (i.e. week 5), and at three- and six months following supervised training.
Secondary outcome [4] 392125 0
Adherence to physical activity and exercise as a composite outcome. Objectively measured using the Actigraph GT3X+ accelerometer, logbook and recorded sessions on Wattbike cycle ergometers. These measures will be assessed to understand global adherence to physical activity and exercise during the maintenance phase.
Timepoint [4] 392125 0
Participants will wear the waist worn device for 7 days immediately before each testing occasion. Baseline, following supervised training (i.e. week 5), and at three- and six months following supervised training. The training logbook will be collected following the participant's final assessment in the parent study (The PEER study) following 12-month testing.
Secondary outcome [5] 392126 0
Quality of life assessed using the FACT-G and SF036 questionnaires
Timepoint [5] 392126 0
Baseline, following supervised training (i.e. week 5), and at three- and six months following supervised training.
Secondary outcome [6] 392127 0
Cancer related fatigue measured using the FACT-F scale
Timepoint [6] 392127 0
Baseline, following supervised training (i.e. week 5), and at three- and six months following supervised training.
Secondary outcome [7] 392128 0
Grip strength assessed using the dynamometer
Timepoint [7] 392128 0
Baseline, following supervised training (i.e. week 5), and at three- and six months following supervised training.
Secondary outcome [8] 392129 0
Depression assessed using the PHQ-9 and DASS questionnaires
Timepoint [8] 392129 0
Baseline, following supervised training (i.e. week 5), and at three- and six months following supervised training.
Secondary outcome [9] 392130 0
Generalised anxiety assessed using the GAD-7
Timepoint [9] 392130 0
Baseline, following supervised training (i.e. week 5), and at three- and six months following supervised training.
Secondary outcome [10] 392131 0
insomnia assessed using the ISI questionnaire
Timepoint [10] 392131 0
Baseline, following supervised training (i.e. week 5), and at three- and six months following supervised training.
Secondary outcome [11] 392133 0
Dietary intake. A three-day food diary will be used to assess factors of dietary intake during the period of sample deposits (i.e. the three days immediately prior to a testing occasion). These recordings will then be analysed for macronutrient composition and total calorie intake using the FoodWorks database.
Timepoint [11] 392133 0
Baseline, following supervised training (i.e. week 5), and at three- and six months following supervised training.

Eligibility
Key inclusion criteria
-Histologically confirmed breast, prostate and colorectal cancer
- Aged 18 years or older
- At least one-month post-cancer treatments and not intending to undergo any further treatment during the study period
- Free of any musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Currently performing high intensity interval training more than four times per month
- Unable to travel to the training/testing facilities
- Unable to give informed consent
- Participant is pregnant or becomes pregnant during the study period

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
From parent study: Data from our previous study (Devin et al., 2015) demonstrated that 4 weeks of HIIT increased cancer survivors (n=36) physical activity levels from 259±556 to 380±424 min of MVPA/week. This is an effect size of Cohen’s d=0.24. Based on the hypothesis that those in the peer support group will maintain these levels of physical activity within 10% of those achieved following 4 weeks of HIIT, and the non-peer support/usual care group will decrease back to baseline, a priori power calculation determined that a sample of n=188 (n=94 per group) would be needed to detect a minimum between group difference of 121±494 min/wk of MVPA, with 5 measurement points, 80% power and 5% alpha. To account for an anticipated dropout rate of 30% (i.e. failure to attend follow-up testing sessions), a target of 244 participants (n=122 per group) would be set for recruitment.
For current study: Data will be analysed using a combination of SPSS and R statistical programming. Histograms and Shapiro-Wilk tests will be used to determine the normality of data. It has been suggested that microbiome data are predominantly non-normally distributed, and non-parametric statistics will likely be used for analysis. Changes in variables between baseline, five-weeks, three-months and six-months of intervention will be examined. Alpha diversity will be assessed using the Shannon index. Differences in taxa at various levels will be evaluated using the Wilcoxon rank testing across timepoints and the Benjamini-Hochberg correction will be used to adjust for false discovery rate and correct for multiple testing. Identification of statistically relevant taxonomic features will be determined with the analysis of composition of microbiomes (ANCOM) test using the R package of the same name. Bivariate correlation analysis will be assessed using Spearman correlation coefficients, except where stated, and employ physical activity parameters, anthropometry, diet, and genera that are common among participants. Covariate analysis will be conducted using diet variables (total energy intake, protein, carbohydrate, lipids, fibre, alcohol and processed meat) and body composition (BMI and DXA results, i.e. fat mass, muscle mass etc.). For the observation of any variables separate to microbiome, differences will be examined using Student’s t-tests. Alpha for all analyses will be set at 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/03/2021
Date of last participant enrolment
Anticipated
7/03/2022
Actual
6/11/2021
Date of last data collection
Anticipated
12/09/2022
Actual
13/05/2022
Sample size
Target
40
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 33228 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 307920 0
Government body
Name [1] 307920 0
National Health and Medical Research
Country [1] 307920 0
Australia
Funding source category [2] 307943 0
Charities/Societies/Foundations
Name [2] 307943 0
Cancer Council Queensland
Country [2] 307943 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Human Movement Studies Building (Building 26B), Blair Drive, The University of Queensland, St Lucia, QLD, 4072
Country
Australia
Secondary sponsor category [1] 308637 0
Charities/Societies/Foundations
Name [1] 308637 0
Cancer Council Queensland
Address [1] 308637 0
553 Gregory Terrace, Fortitude Valley, QLD, 4006
Country [1] 308637 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307918 0
Bellberry Limited
Ethics committee address [1] 307918 0
129 Glen Osmond Road Eastwood Adelaide South Australia 5063
Ethics committee country [1] 307918 0
Australia
Date submitted for ethics approval [1] 307918 0
13/10/2020
Approval date [1] 307918 0
21/10/2020
Ethics approval number [1] 307918 0
2015-12-840-A-10

Summary
Brief summary
The purpose of this study is to determine whether high intensity interval training can improve health outcomes and influence the gut micro biome in breast, prostate and colorectal cancer survivors.

Who is it for?

You may be eligible for this study if you are an adult with confirmed breast, prostate or colorectal cancer, and are at least one month post-treatment completion for cancer.

Study details:

All participants will undertake an initial 4-week supervised training phase, with 3 sessions per week of exercise with an Accredited Exercise Physiologist or equivalent. Following the supervised phase, participants will enter a 6-month maintenance period where they will be asked to maintain 150 minutes of moderate intensity or 75 minutes of vigorous intensity or a combination, therefore meeting the Australian exercise oncology guidelines.

It is hoped that this research will help determine if exercise, and especially high intensity exercise, is effective in positively influencing the gut microbiome and other health outcomes in cancer survivors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108926 0
Miss Chloe Salisbury
Address 108926 0
School of Human Movement and Nutrition Sciences Level 5, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 108926 0
Australia
Phone 108926 0
+61 4282 456 33
Fax 108926 0
+61 7 33656877
Email 108926 0
[email protected]
Contact person for public queries
Name 108927 0
Mr Alexander Boytar
Address 108927 0
School of Human Movement and Nutrition Sciences Level 5, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 108927 0
Australia
Phone 108927 0
+61 4282 456 33
Fax 108927 0
+61 7 33656877
Email 108927 0
[email protected]
Contact person for scientific queries
Name 108928 0
Mr Alexander Boytar
Address 108928 0
School of Human Movement and Nutrition Sciences Level 5, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 108928 0
Australia
Phone 108928 0
+61 4282 456 33
Fax 108928 0
+61 7 33656877
Email 108928 0
[email protected]

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.