ANZCTR - Registration

Registration number

ACTRN12623000888662

Ethics application status

Approved

Date submitted

19/07/2023

Date registered

21/08/2023

Date last updated

4/08/2024

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer

Condition category

Condition code

Cancer

Breast

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Cancer

Lung - Non small cell

Cancer

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]

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]

Chemotherapy completion rate will be assessed as the relative dose intensity (RDI) extracted from patient medical records.

Timepoint [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.

Secondary outcome [1]

The percentage of patients with a RDI <85% assessed via audit of medical records.

Timepoint [1]

At the conclusion of the study.

Secondary outcome [2]

Aerobic fitness will be assessed by means of an incremental submaximal exercise test performed on a cycle ergometer.

Timepoint [2]

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]

Lower extremity muscle strength will be assessed using a leg-press hypothetical 1-RM (h1-RM) test.

Timepoint [3]

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]

Physical function will be assessed with the 30 sec sit-to-stand test.

Timepoint [4]

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]

Balance will be assessed with the one-legged stance with open and closed eyes.

Timepoint [5]

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]

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]

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]

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]

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]

Fatigue: Cancer-related fatigue will be assessed using the EORTC QLQ-FA12.

Timepoint [8]

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]

Chemotherapy-induced Peripheral Neuropathies: Chemotherapy-induced Peripheral Neuropathies will be assessed using the EORTC QLQ-CIPN20.

Timepoint [9]

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]

Anxiety will be assessed using the Generalised Anxiety Disorder Assessment (GAD-7).

Timepoint [10]

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]

Physical activity levels: Self-reported physical activity will be assessed with the modified Godin Leisure-Time Exercise Questionnaire.

Timepoint [11]

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]

Hospitalisations: Number of hospitalisations and reasons for hospitalisations will be extracted from patient medical records

Timepoint [12]

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]

Blood biomarkers: Routine blood biomarkers will be extracted from medical records (e.g. hemoglobin, neutrophil, lymphocyte, and thrombocyte concentrations).

Timepoint [13]

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]

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]

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]

Height will be measured using a wall mounted stadiometer

Timepoint [15]

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]

Weight will be measured using digital scales.

Timepoint [16]

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]

Overall survival, defined as time from diagnosis to death from any cause will be extracted from medical records.

Timepoint [17]

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]

Cancer-specific survival, defined as time from diagnosis to death from cancer will be extracted from medical records.

Timepoint [18]

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]

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]

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]

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]

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]

Depression will be assessed using the Patient Health Questionnaire - 9 (PHQ-9).

Timepoint [21]

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]

The percentage of patients that experienced dose adjustments or delays during adjuvant chemotherapy assessed via audit of medical records.

Timepoint [22]

At the conclusion of the study.

Secondary outcome [23]

Reasons for any dose adjustments experienced during adjuvant chemotherapy assessed via audit of medical records.

Timepoint [23]

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]

The percentage of patients that experienced discontinuation of adjuvant chemotherapy treatment assessed via audit of medical records.

Timepoint [24]

At the conclusion of the study.

Secondary outcome [25]

Exercise capacity will be assessed by means of a Steep Ramp Test performed on a cycle ergometer.

Timepoint [25]

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]

Upper extremity muscle strength will be assessed using a chest-press h1-RM test.

Timepoint [26]

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]

Fat mass will be assessed with an InBody Body Composition Analyser (InBody 770) and dual-energy x-ray absorptiometry (DXA) scan.

Timepoint [27]

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]

Lean body mass will be assessed with an InBody Body Composition Analyser (InBody 770) and dual-energy x-ray absorptiometry (DXA) scan.

Timepoint [28]

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]

Waist circumference will be assessed using a flexible measuring tape.

Timepoint [29]

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]

Hip circumference will be assessed using a flexible measuring tape.

Timepoint [30]

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]

Grip strength will be assessed using a handgrip dynamometer.

Timepoint [31]

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]

Reasons for any dose delay experienced during adjuvant chemotherapy assessed via audit of medical records.

Timepoint [32]

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

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/09/2023

Actual

8/03/2024

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

252

Accrual to date

7

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Cabrini Hospital - Malvern - Malvern

Recruitment postcode(s) [1]

3144 - Malvern

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Cabrini Foundation

Country [1]

Australia

Primary sponsor type

Hospital

Name

Cabrini Health

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

Research Support Services
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/07/2023

Approval date [1]

01/09/2023

Ethics approval number [1]

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

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

Dr Eva Zopf

Address

Cancer Exercise Lab, Cabrini Cancer Institute
183 Wattletree Rd, Malvern VIC 3144

Country

Australia

Phone

+610395081866

Email

[email protected]

Contact person for public queries

Name

Eva Zopf

Address

Cancer Exercise Lab, Cabrini Cancer Institute
183 Wattletree Rd, Malvern VIC 3144

Country

Australia

Phone

+610395081866

Email

[email protected]

Contact person for scientific queries

Name

Eva Zopf

Address

Cancer Exercise Lab, Cabrini Cancer Institute
183 Wattletree Rd, Malvern VIC 3144

Country

Australia

Phone

+610395081866

Email

[email protected]

Trial Review

Documents added manually

Documents added automatically