Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000888662p
Ethics application status
Submitted, not yet approved
Date submitted
19/07/2023
Date registered
21/08/2023
Date last updated
21/08/2023
Date data sharing statement initially provided
21/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of exercise on chemotherapy completion rates in cancer patients receiving adjuvant chemotherapy - The ChemoFit Study
Scientific title
The effect of exercise on chemotherapy completion rates in adult cancer patients with solid tumours receiving adjuvant chemotherapy - The ChemoFit Study
Secondary ID [1] 310062 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 330599 0
Condition category
Condition code
Cancer 327546 327546 0 0
Breast
Cancer 327571 327571 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 327572 327572 0 0
Lung - Non small cell
Cancer 327573 327573 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise intervention
Participants will be offered two supervised exercise sessions/week throughout the course of their chemotherapy treatment plus 2 weeks (max. 8 months). The exercise sessions will be conducted in small groups under the direct supervision of an exercise physiologist (EP) and last approximately 60 minutes. Prior to commencing the program, each participant will receive a consultation with the EP (as part of their baseline assessment) in order to individualise the exercise prescription to their specific needs according to their cancer and general health history, and physical abilities. The individualised prescription (i.e. specific exercise selection, intensity and progression) will be designed in accordance with national and international guidelines for best practice in exercise prescription for people with cancer, involving a combination of aerobic, resistance, and balance exercise (American College of Sports Medicine, Clinical Oncology Society of Australia, Exercise and Sports Science Australia). Specifically, the aerobic exercise component will include 20 to 25 minutes of moderate intensity continuous to vigorous intensity cardiovascular exercise (~60-85% of estimated maximum heart rate) using a variety of modes such as walking or jogging on a treadmill or cycling on a stationary ergometer. Participants will be encouraged to undertake additional home-based aerobic exercise with the goal of achieving a total of at least 150 minutes of moderate to vigorous intensity aerobic exercise each week. The resistance exercise component will last approximately 25 minutes and involve 4-6 exercises that target the major upper and lower body muscle groups (e.g. chest press, leg press). Intensity will be manipulated from 6-12 repetition maximum (RM; i.e. the maximal weight that can be lifted 6 to 12 times which is equivalent to ~60-85% of 1RM) using 2-3 sets per exercise. Exercise prescription will be progressive and modified according to individual response. The aim will be for patients to exercise with an intensity that they perceive as being “somewhat hard” to “hard” (rating between 12 and 15 on The Borg Rating of Perceived Exertion Scale). The balance exercise component will last 5 to 10 minutes, include exercises that involve a variety of different stances (e.g., single leg, tandem balance) and will be progressed by including more challenging tasks. Exercise session frequency (i.e. attendance) as well as adherence to supervised aerobic and resistance exercise (i.e. prescribed vs completed training volume) will be recorded. This includes early session terminations, exercise or dose (e.g. number of sets, repetitions, or load reductions) modifications but also dose escalations. Reasons for any missed exercise sessions (e.g. conflicting appointment) and changes in exercise prescription (e.g. fatigue) will be documented by study team members.
Intervention code [1] 326468 0
Lifestyle
Comparator / control treatment
Historical control group
A historical control cohort will be randomly selected patients from the hospital patient database. Control patients will be matched to the intervention group using cancer type, treatment, sex and age at diagnosis. Data collected between 2021 and 2031 will be obtained from multiple data sources at Cabrini Health (incl. Data Warehouse, Patient Administration System, chemotherapy database, and in-house oncology databases).
Control group
Historical

Outcomes
Primary outcome [1] 335298 0
Chemotherapy completion rate will be assessed as the relative dose intensity (RDI) extracted from patient medical records.
Timepoint [1] 335298 0
Post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [1] 423798 0
The percentage of patients with a RDI <85% assessed via audit of medical records.
Timepoint [1] 423798 0
At the conclusion of the study.
Secondary outcome [2] 424319 0
Aerobic fitness will be assessed by means of an incremental submaximal exercise test performed on a cycle ergometer.
Timepoint [2] 424319 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation) and post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [3] 424321 0
Lower extremity muscle strength will be assessed using a leg-press hypothetical 1-RM (h1-RM) test.
Timepoint [3] 424321 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation) and post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [4] 424322 0
Physical function will be assessed with the 30 sec sit-to-stand test.
Timepoint [4] 424322 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation) and post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [5] 424323 0
Balance will be assessed with the one-legged stance with open and closed eyes.
Timepoint [5] 424323 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation) and post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [6] 424325 0
Nutritional Status: The Patient-Generated-Subjective Global Assessment (PG-SGA) - Short Form will be administered to evaluate patient-reported weight-loss, change in food intake, and performance. This will be assessed as a composite outcome.
Timepoint [6] 424325 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation), mid-assessment: mid-way through through their (scheduled) chemotherapy regimen, and at two time points following adjuvant chemotherapy 1) post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first and 2) 3-month follow-up: three months following the post assessment.
Secondary outcome [7] 424326 0
Quality of life: Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.
Timepoint [7] 424326 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation), mid-assessment: mid-way through through their (scheduled) chemotherapy regimen, and at two time points following adjuvant chemotherapy 1) post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first and 2) 3-month follow-up: three months following the post assessment.
Secondary outcome [8] 424327 0
Fatigue: Cancer-related fatigue will be assessed using the EORTC QLQ-FA12.
Timepoint [8] 424327 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation), mid-assessment: mid-way through through their (scheduled) chemotherapy regimen, and at two time points following adjuvant chemotherapy 1) post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first and 2) 3-month follow-up: three months following the post assessment.
Secondary outcome [9] 424328 0
Chemotherapy-induced Peripheral Neuropathies: Chemotherapy-induced Peripheral Neuropathies will be assessed using the EORTC QLQ-CIPN20.
Timepoint [9] 424328 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation), mid-assessment: mid-way through through their (scheduled) chemotherapy regimen, and at two time points following adjuvant chemotherapy 1) post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first and 2) 3-month follow-up: three months following the post assessment.
Secondary outcome [10] 424329 0
Anxiety will be assessed using the Generalised Anxiety Disorder Assessment (GAD-7).
Timepoint [10] 424329 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation), mid-assessment: mid-way through through their (scheduled) chemotherapy regimen, and at two time points following adjuvant chemotherapy 1) post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first and 2) 3-month follow-up: three months following the post assessment.
Secondary outcome [11] 424330 0
Physical activity levels: Self-reported physical activity will be assessed with the modified Godin Leisure-Time Exercise Questionnaire.
Timepoint [11] 424330 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation), mid-assessment: mid-way through through their (scheduled) chemotherapy regimen, and at two time points following adjuvant chemotherapy 1) post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first and 2) 3-month follow-up: three months following the post assessment.
Secondary outcome [12] 424331 0
Hospitalisations: Number of hospitalisations and reasons for hospitalisations will be extracted from patient medical records
Timepoint [12] 424331 0
Post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [13] 424332 0
Blood biomarkers: Routine blood biomarkers will be extracted from medical records (e.g. hemoglobin, neutrophil, lymphocyte, and thrombocyte concentrations).
Timepoint [13] 424332 0
Post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [14] 424333 0
Inflammatory biomarkers (e.g. CRP, IL-6, TNFa) will be evaluated from a venous blood sample (12 mL blood; serum and plasma samples).
Timepoint [14] 424333 0
Post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [15] 424334 0
Height will be measured using a wall mounted stadiometer
Timepoint [15] 424334 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation) and post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [16] 424335 0
Weight will be measured using digital scales.
Timepoint [16] 424335 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation) and post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [17] 424337 0
Overall survival, defined as time from diagnosis to death from any cause will be extracted from medical records.
Timepoint [17] 424337 0
5 years following post-assessment (within 4 weeks of the last chemotherapy cycle or 8 months after the first exercise session, whichever comes first).
Secondary outcome [18] 424338 0
Cancer-specific survival, defined as time from diagnosis to death from cancer will be extracted from medical records.
Timepoint [18] 424338 0
5 years following post-assessment (within 4 weeks of the last chemotherapy cycle or 8 months after the first exercise session, whichever comes first).
Secondary outcome [19] 424339 0
Progression-free survival, defined as time from diagnosis to time of recurrence, or death from any cause will be extracted from medical records.
Timepoint [19] 424339 0
5 years following post-assessment (within 4 weeks of the last chemotherapy cycle or 8 months after the first exercise session, whichever comes first).
Secondary outcome [20] 424341 0
Adverse Events will be monitored and reported throughout the trial by the supervising exercise physiologist. Additionally, participants will self-report incidence and severity of any exercise-related adverse events using a custom questionnaire.
Timepoint [20] 424341 0
Throughout the trial and at post-assessment (within 4 weeks of the last chemotherapy cycle or 8 months after the first exercise session, whichever comes first).
Secondary outcome [21] 424343 0
Depression will be assessed using the Patient Health Questionnaire - 9 (PHQ-9).
Timepoint [21] 424343 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation), mid-assessment: mid-way through through their (scheduled) chemotherapy regimen, and at two time points following adjuvant chemotherapy 1) post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first and 2) 3-month follow-up: three months following the post assessment.
Secondary outcome [22] 425061 0
The percentage of patients that experienced dose adjustments or delays during adjuvant chemotherapy assessed via audit of medical records.
Timepoint [22] 425061 0
At the conclusion of the study.
Secondary outcome [23] 425065 0
Reasons for any dose adjustments experienced during adjuvant chemotherapy assessed via audit of medical records.
Timepoint [23] 425065 0
Post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [24] 425067 0
The percentage of patients that experienced discontinuation of adjuvant chemotherapy treatment assessed via audit of medical records.
Timepoint [24] 425067 0
At the conclusion of the study.
Secondary outcome [25] 425074 0
Exercise capacity will be assessed by means of a Steep Ramp Test performed on a cycle ergometer.
Timepoint [25] 425074 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation) and post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [26] 425076 0
Upper extremity muscle strength will be assessed using a chest-press h1-RM test.
Timepoint [26] 425076 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation) and post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [27] 425079 0
Fat mass will be assessed with an InBody Body Composition Analyser (InBody 770) and dual-energy x-ray absorptiometry (DXA) scan.
Timepoint [27] 425079 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation) and post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first..
Secondary outcome [28] 425081 0
Lean body mass will be assessed with an InBody Body Composition Analyser (InBody 770) and dual-energy x-ray absorptiometry (DXA) scan.
Timepoint [28] 425081 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation) and post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [29] 425097 0
Waist circumference will be assessed using a flexible measuring tape.
Timepoint [29] 425097 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation) and post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [30] 425098 0
Hip circumference will be assessed using a flexible measuring tape.
Timepoint [30] 425098 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation) and post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [31] 425107 0
Grip strength will be assessed using a handgrip dynamometer.
Timepoint [31] 425107 0
Baseline: prior to adjuvant chemotherapy (or within the first three weeks of initiation) and post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.
Secondary outcome [32] 425156 0
Reasons for any dose delay experienced during adjuvant chemotherapy assessed via audit of medical records.
Timepoint [32] 425156 0
Post-assessment: following adjuvant chemotherapy (within 4 weeks of the last chemotherapy cycle) or 8 months after the first exercise session, whichever comes first.

Eligibility
Key inclusion criteria
1) Diagnosed with a solid tumour (stages I-III),
2) Scheduled for first-line adjuvant chemotherapy with curative intent,
3) Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2,
4) Greater than or equal to 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Other actively treated cancer (expect for non-melanoma skin cancer),
2) Having received chemotherapy previously,
3) Any medical condition that could place the participant at unreasonable risk of injury or illness caused by the exercise testing or training;
4) Pregnant
5) Unable to read, speak or understand English (and no interpreter).

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
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A single-arm intervention and a historical control group will be used.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
252
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25199 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 40869 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 314227 0
Charities/Societies/Foundations
Name [1] 314227 0
Cabrini Foundation
Country [1] 314227 0
Australia
Primary sponsor type
Hospital
Name
Cabrini Health
Address
Cabrini Malvern. 183 Wattletree Rd, Malvern, VIC, 3144
Country
Australia
Secondary sponsor category [1] 316160 0
None
Name [1] 316160 0
Address [1] 316160 0
Country [1] 316160 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313350 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 313350 0
Research Support Services
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 313350 0
Australia
Date submitted for ethics approval [1] 313350 0
19/07/2023
Approval date [1] 313350 0
Ethics approval number [1] 313350 0

Summary
Brief summary
This study aims to explore whether participating in exercise during adjuvant chemotherapy can improve treatment tolerance and more specifically chemotherapy completion rates.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, have been diagnosed with a stage I-III solid tumour and are scheduled to receive chemotherapy.

Study details
Participants will be offered twice-weekly supervised small group exercise sessions for the duration of their adjuvant chemotherapy, or for a maximum of 8 months. Exercise sessions will last approximately 60 minutes and involve a combination of aerobic, resistance, and balance exercises. Participants will also be encouraged to engage in additional aerobic exercises at home with the goal of reaching a total of at least 150 minutes of moderate to vigorous intensity aerobic exercise each week. Data on chemotherapy completion, physical and mental wellbeing will be collected before, during and after the intervention.

It is hoped that information from this study will help determine whether participating in exercise during adjuvant chemotherapy has a beneficial effect on chemotherapy completion rates and physical and mental wellbeing in people diagnosed with cancer.
Trial website
Trial related presentations / publications
Public notes
Patients diagnosed with any solid tumour (stages I-III) that are scheduled for adjuvant chemotherapy are eligible. The most common tumours have been listed above but others are eligible as well.

Contacts
Principal investigator
Name 127838 0
Dr Eva Zopf
Address 127838 0
Cancer Exercise Lab, Cabrini Cancer Institute
183 Wattletree Rd, Malvern VIC 3144
Country 127838 0
Australia
Phone 127838 0
+610395081866
Fax 127838 0
Email 127838 0
ezopf@cabrini.com.au
Contact person for public queries
Name 127839 0
Dr Eva Zopf
Address 127839 0
Cancer Exercise Lab, Cabrini Cancer Institute
183 Wattletree Rd, Malvern VIC 3144
Country 127839 0
Australia
Phone 127839 0
+610395081866
Fax 127839 0
Email 127839 0
ezopf@cabrini.com.au
Contact person for scientific queries
Name 127840 0
Dr Eva Zopf
Address 127840 0
Cancer Exercise Lab, Cabrini Cancer Institute
183 Wattletree Rd, Malvern VIC 3144
Country 127840 0
Australia
Phone 127840 0
+610395081866
Fax 127840 0
Email 127840 0
ezopf@cabrini.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study protocol approved through the human research ethics committee does not permit sharing IPD


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.