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Trial registered on ANZCTR


Registration number
ACTRN12614000350628
Ethics application status
Approved
Date submitted
19/03/2014
Date registered
1/04/2014
Date last updated
6/06/2019
Date data sharing statement initially provided
18/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised study to evaluate the impact of Aerobic and Resistance Exercise on fatigue in patients with advanced breast cancer
Scientific title
Randomised study to evaluate the impact of Aerobic and Resistance Exercise on fatigue in patients with advanced breast cancer (AREA study)
Secondary ID [1] 284279 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AREA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue in patients with Advanced Breast Cancer 291416 0
Condition category
Condition code
Cancer 291778 291778 0 0
Breast
Physical Medicine / Rehabilitation 291779 291779 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 6 Week Exercise Program which will be offered as 1 hour sessions twice a week for 6 weeks.
The Exercise sessions include:
1. 10 minutes of warm-up using the large muscle groups in arms & legs on a treadmill, bike or rowing machine (mild paced and customized to individual capability)
2. 30 minutes of resistance exercise against own body weight or the weight of an object using arms and legs (customized to individual capability)
3. The last 10 minutes is for stretching exercises.

The exercise sessions will be conducted at the Specialist Sports and Spinal Physiotherapy, Nedlands, WA 6009. It will conducted under supervision of an experienced physiotherapist and will be either individual sessions or a group session of not more than 4 participants.

The study will be conducted in two parts. In Part 1, the exercise program will be offered to approx. 8 eligible patients over a 6-week duration, where the primary endpoint will be to assess feasibility and overall safety. If 80% of the exercise program is completed in greater than or equal to 75% of recruited patients (i.e. at least 6 of 8 patients) without occurrence of a serious adverse event occurring during the exercise program (as assessed by the study physiotherapist and treating clinician), the exercise program will be deemed as being feasible and safe to move into Part 2 of the study.
In the event that a serious adverse event occurs during the exercise program, a modified exercise program will be evaluated in a further group of 8 patients. If 80% of the exercise program is completed in greater than or equal to 75% of recruited patients (i.e. at least 6 of 8 patients) without occurrence of a serious adverse event occurring during the modified exercise program (as assessed by the study physiotherapist and treating clinician), the exercise program will be deemed as being feasible.

In Part 2, the 6 Week program will be offered to a larger group of patients to evaluate for an improvement in levels of fatigue experienced by patients with Metastatic Breast Cancer.
Intervention code [1] 289007 0
Treatment: Other
Intervention code [2] 289030 0
Lifestyle
Comparator / control treatment
Participants will be randomized in a 1:1 ratio to either the Treatment group (will participate in Exercise program) and the Control group (will not participate in Exercise program).
Control group
Active

Outcomes
Primary outcome [1] 291722 0
To assess the improvement in fatigue as measured by FACIT-F in patients with metastatic breast cancer who undergo a specific exercise program.
Timepoint [1] 291722 0
After completion of the 6 week Exercise program.
Secondary outcome [1] 307354 0
1. Compliance with the exercise program will be defined as those patients who can complete 80% of the exercise program (i.e. greater than or equal to 480 minutes in total) over the study period.
Timepoint [1] 307354 0
After completion of the 6 week Exercise program.
Overall compliance with 6-week program will be assessed by measurement of the amount of time spent in the exercise program with the study investigator. Satisfactory compliance will be defined as greater than or equal to 80% completion of the planned 600 minutes of the total exercise program (i.e. 480 minutes).
Secondary outcome [2] 307386 0
2. Change in 6-minute walk test at end of study evaluation - this will be assessed by the physiotherapists who are also co-investigators for the study.
Timepoint [2] 307386 0
At Screening and End of Study (end of study visit is within 14-21 days from Week 6 visit)
Secondary outcome [3] 307388 0
3. Frequency and severity of depression - to be assessed by the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Timepoint [3] 307388 0
At Screening, Week 1, Week 4 & End of Study (end of study visit is within 14-21 days from Week 6 visit)
To be assessed by the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Secondary outcome [4] 307401 0
Association of fatigue score with levels of depression and pain. This will be assessed by the study questionnaires - HADS, FACIT - F, VAS, BPI.
Timepoint [4] 307401 0
This will be assessed by the study questionnaires - HADS, FACIT - F, VAS, BPI.
At Screening, Week 1, Week 4 & End of Study (end of study visit is within 14-21 days from Week 6 visit) for the HADS & FACIT-F
At Screening, Week 4 and End of Study (end of study visit is within 14-21 days from Week 6 visit) for the VAS & BPI questionnaires.
Secondary outcome [5] 307402 0
Adverse effects. Assessment of adverse events will be done during the entire study - Participants will complete the study questionnaires - HADS, Visual Analogue Scale (Pain), Brief Pain Inventory (BPI), FACIT - F. They will also have a review with a study nurse every week.
Participants will also be given a Participant Diary to record any adverse events/symptoms they experience during the week and also any medications taken for those symptoms/adverse events.
A previous study where Prostate cancer patients with Bone metastases participated in a supervised exercise program - reported nil adverse events during the exercise sessions. Also nil changes in use of pain medication during the study was reported.
To date, from published studies in this area, there are no other known/possible adverse events that are known of related to the exercises being used in this study.
Timepoint [5] 307402 0
Adverse events will be assessed every week.
Assessment of adverse events will be done during the entire study - Participants will complete the study questionnaires - HADS, Visual Analogue Scale (Pain), Brief Pain Inventory (BPI), FACIT - F. They will also have a review with a study nurse every week.
Participants will also be given a Participant Diary to record any adverse events/symptoms they experience during the week and also any medications taken for those symptoms/adverse events.

Eligibility
Key inclusion criteria
1. Metastatic breast cancer patients >=18 years of age and managed at BCRC-WA, who have experienced subjective fatigue in the past several weeks as a persistent symptom
2. Assessed by the treating oncologist within the past 3 months as having stable metastatic disease on current systemic treatment.
3. Performance status (ECOG) of 0-2
4. Life expectancy of greater than 6-months
5. English speaking
6. Able to walk continuously (non-stop) at a comfortable pace for a minimum of 6 minutes or 120 meters.
7. Able to maintain compliance with study treatment and assessments
8. Signed informed consent
Minimum age
18 Years
Maximum age
80 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients >80 years of age
2. Patient requiring domiciliary oxygen
3. Anticipated to require a change in systemic therapy within the next 60 days
4. Active cardiac disease, defined as one or more of the following: occurring <6 months from informed consent -
- Uncontrolled or unstable angina
- Uncontrolled arrhythmias, or arrhythmias deemed clinically significant by the investigator
- Myocardial infarction or cardiac stenting less than 6 months earlier or angioplasty
- Uncontrolled or symptomatic congestive heart failure
5. Significant peripheral arterial disease (Ankle brachial index < 0.50)
6. Chronic obstructive lung disease (Pulmonary Function Test within the past 6 months with FEV1 < 40%)
7. Severe musculoskeletal condition
8. Symptomatic psychological or psychiatric condition which would preclude adherence to study protocol
9. In patients with known bone metastases, patients with lytic metastatic lesions involving the long bones will be excluded
10. Patients who are already participating in an established routine of physical activity or structured exercise program of greater than or equal to 30 minutes, 2 to 3 times/week.


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)
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
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4536 0
Breast Cancer Research Centre - Western Australia - Perth
Recruitment postcode(s) [1] 13243 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 288916 0
Other
Name [1] 288916 0
Breast Cancer Research Centre - WA
Address [1] 288916 0
Breast Cancer Research Centre-WA
Hollywood Private Hospital
Entrance 3, Lower Ground Floor
101 Monash Avenue
Nedlands WA 6009
Country [1] 288916 0
Australia
Primary sponsor type
Other
Name
Breast Cancer Research Centre - WA
Address
Breast Cancer Research Centre-WA
Hollywood Private Hospital
Entrance 3, Lower Ground Floor
101 Monash Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 287611 0
None
Name [1] 287611 0
Address [1] 287611 0
Country [1] 287611 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290746 0
Bellberry HREC
Ethics committee address [1] 290746 0
Ethics committee country [1] 290746 0
Australia
Date submitted for ethics approval [1] 290746 0
26/03/2014
Approval date [1] 290746 0
30/05/2014
Ethics approval number [1] 290746 0

Summary
Brief summary
The study will assess the feasibility of a specified exercise program in patients with advanced breast cancer and its impact on improving fatigue.

Who is it for?
You may be eligible to join this study if you are a female with metastatic breast cancer aged between 18-80 years, and are being managed at Breast Cancer Research Centre- WA. Eligible women will also have experienced subjective fatigue in the past several weeks as a persistent symptom.

Study details
This study will be conducted in two parts. In Part 1, eligible patients will be offered a 6 week exercise program, where the primary endpoint will be to assess feasibility and overall safety. If the program is deemed as being feasible and safe, Part 2 of the study will commence. In Part 2, participants will be randomly (by chance) allocated to one of two groups. Participants in one group will be offered the 6 week exercise program, whilst participants in the other group will not participate in the exercise program.
On completion of the program, participants will be asked to complete some questionnaires to assess their levels of fatigue, depression and pain. They will also be asked to conduct a brief walking test to assess any changes in aerobic fitness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47006 0
Prof Arlene Chan
Address 47006 0
Breast Cancer Research Centre-WA
Hollywood Private Hospital
Entrance 3, Lower Ground Floor
101 Monash Avenue
Nedlands WA 6009
Country 47006 0
Australia
Phone 47006 0
+61 08 94814522
Fax 47006 0
Email 47006 0
arlenechan@me.com
Contact person for public queries
Name 47007 0
Mrs Jeannette Devoto
Address 47007 0
Breast Cancer Research Centre-WA
Hollywood Private Hospital
Entrance 3, Lower Ground Floor
101 Monash Avenue
Nedlands WA 6009
Country 47007 0
Australia
Phone 47007 0
+61 8 6500 5555
Fax 47007 0
Email 47007 0
BCTU@bcrc-wa.com.au
Contact person for scientific queries
Name 47008 0
Mrs Jeannette Devoto
Address 47008 0
Breast Cancer Research Centre-WA
Hollywood Private Hospital
Entrance 3, Lower Ground Floor
101 Monash Avenue
Nedlands WA 6009
Country 47008 0
Australia
Phone 47008 0
+61 8 6500 5555
Fax 47008 0
Email 47008 0
BCTU@bcrc-wa.com.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?
data will only be shared amongst participating investigators as pertains to the study endpoints and specified analyses
When will data be available (start and end dates)?
At time of data clean and first data analysis and up until time of final publication
Available to whom?
participating investigators
Available for what types of analyses?
Analyses as planned per protocol, or as exploratory analyses based on study's findings which may serve as rationale for further clinical research evaluation
How or where can data be obtained?
Data fields from primary study database will be shared as deidentified records in Excel spreadsheet.
What supporting documents are/will be available?
No other documents available
Summary results
No Results