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Trial registered on ANZCTR


Registration number
ACTRN12614000051640
Ethics application status
Approved
Date submitted
9/01/2014
Date registered
17/01/2014
Date last updated
3/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing ‘chemo-brain’: Can exercise mitigate chemotherapy-induced cognitive impairment in breast cancer patients?
Scientific title
Preventing ‘chemo-brain’: Can exercise mitigate chemotherapy-induced cognitive impairment in breast cancer patients?
Secondary ID [1] 283882 0
Nil
Universal Trial Number (UTN)
U1111-1151-9968
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 290867 0
Condition category
Condition code
Cancer 291226 291226 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EXERCISE INTERVENTION
The physical exercise intervention program will include a combination of resistance (i.e. lifting weights) and aerobic exercise (e.g. walking, jogging, cycling) undertaken 2 times per week in an exercise clinic. The intensity of the exercise will be moderate to high (i.e. a perceived exertion of somewhat hard to hard) and will be relative to each patients capabilities. The exercise prescription will be progressive and modified according to individual response. Exercise sessions will take approximately 60 minutes and will be conducted in small groups under the supervision of an accredited exercise physiologist. The exercise program will be implemented when patients are receiving chemotherapy. The length of the program will vary from 2.5 to 4 months according to the duration of the chemotherapy regime each patient is prescribed.
Intervention code [1] 288556 0
Lifestyle
Comparator / control treatment
USUAL CARE
The control group will maintain usual care throughout chemotherapy and for 3 months after the completion of chemotherapy treatment. Usual care involves standard medical treatment of breast cancer. Participants will then be offered participation in the physical exercise intervention program.
Control group
Active

Outcomes
Primary outcome [1] 291219 0
Cognitive function as determined by the Hopkins Verbal Learning Test-Revised, the Trail Making Test and the Controlled Oral Word Association of the Multilingual Aphasia Examination.
Timepoint [1] 291219 0
Baseline (7-10 days before chemotherapy), post-chemotherapy (7-10 days after final chemotherapy administration) and follow-up (3 months post-chemotherapy).
Secondary outcome [1] 306253 0
Quality of life as determined by the the Medical Outcomes Short Form 36 and the Functional Assessment of Cancer Therapy for patients with breast cancer questionnaire.
Timepoint [1] 306253 0
Baseline (7-10 days before chemotherapy), post-chemotherapy (7-10 days after final chemotherapy administration) and follow-up (3 months post-chemotherapy).
Secondary outcome [2] 306254 0
Psychological distress as determined by the Brief Symptom Inventory-18 (BSI-18) and the Hospital Anxiety and Depression Scale.
Timepoint [2] 306254 0
Baseline (7-10 days before chemotherapy), post-chemotherapy (7-10 days after final chemotherapy administration) and follow-up (3 months post-chemotherapy).
Secondary outcome [3] 306255 0
Fatigue as determined by the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire.
Timepoint [3] 306255 0
Baseline (7-10 days before chemotherapy), post-chemotherapy (7-10 days after final chemotherapy administration) and follow-up (3 months post-chemotherapy).
Secondary outcome [4] 306256 0
Neuropathies as determined by the Functional Assessment of Cancer Therapy-Neurotoxicity questionnaire.
Timepoint [4] 306256 0
Baseline (7-10 days before chemotherapy), post-chemotherapy (7-10 days after final chemotherapy administration) and follow-up (3 months post-chemotherapy).
Secondary outcome [5] 306257 0
Musculoskeletal symptoms including myalgias and arthralgias as determined by the Muscle and Joint Measure questionnaire.
Timepoint [5] 306257 0
Baseline (7-10 days before chemotherapy), post-chemotherapy (7-10 days after final chemotherapy administration) and follow-up (3 months post-chemotherapy).
Secondary outcome [6] 306258 0
Sleep quality as determined by the Insomnia Severity Index.
Timepoint [6] 306258 0
Baseline (7-10 days before chemotherapy), post-chemotherapy (7-10 days after final chemotherapy administration) and follow-up (3 months post-chemotherapy).
Secondary outcome [7] 306259 0
Physical function as determined by 400-m walk (aerobic capacity), one repetition maximum in the leg press (muscular strength), repeated chair rise (muscular power), usual and fast pace 6-m walk (ambulation), backwards tandem 6-m walk (dynamic balance) and sensory organisation test (static balance).
Timepoint [7] 306259 0
Baseline (7-10 days before chemotherapy), post-chemotherapy (7-10 days after final chemotherapy administration) and follow-up (3 months post-chemotherapy).
Secondary outcome [8] 306260 0
Physical activity level as determined by the Godin Leisure-Time Exercise Questionnaire.
Timepoint [8] 306260 0
Baseline (7-10 days before chemotherapy), post-chemotherapy (7-10 days after final chemotherapy administration) and follow-up (3 months post-chemotherapy).

Eligibility
Key inclusion criteria
1. Woman diagnosed with breast cancer

2. Scheduled to receive adjuvant chemotherapy with fluorouracil-epirubicin-cyclophosphamide- docetaxel (FEC-T) or docetaxel-cyclophosphamide (TC) regimens
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A pre-existing cognitive impairment or mental health issue

2. Any acute illness or disorder that could inhibit exercise participation or put participants at risk from exercising

3. Inability to read and understand English.

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)
Central randomisation by computer. Written informed consent will be required prior to any testing or randomisation. Participants who dropout prior to completing baseline testing will not be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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] 1943 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 2700 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 7686 0
6000 - Perth
Recruitment postcode(s) [2] 8412 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 288525 0
University
Name [1] 288525 0
Cancer and Palliative Care Research and Evaluation Unit, The University of Western Australia
Address [1] 288525 0
Cancer and Palliative Care Research and Evaluation Unit
The University of Western Australia
35 Stirling Highway
Crawley WA 6009
Country [1] 288525 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
ECU Health and Wellness Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 287235 0
Individual
Name [1] 287235 0
Dr Prue Cormie
Address [1] 287235 0
ECU Health and Wellness Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country [1] 287235 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290387 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 290387 0
Ethics Office
Royal Perth Hospital
Colonial House, Murray Street
Perth WA 6000
Ethics committee country [1] 290387 0
Australia
Date submitted for ethics approval [1] 290387 0
09/01/2014
Approval date [1] 290387 0
31/03/2014
Ethics approval number [1] 290387 0

Summary
Brief summary
This project will determine if exercise reduces or even prevents cognitive impairment in breast cancer patients receiving chemotherapy. Who is it for? You may be eligible to join if you are a female aged 18 years and over and are scheduled to receive adjuvant chemotherapy for the treatment of breast cancer with fluorouracil-epirubicin-cyclophosphamide- docetaxel (FEC-T) or docetaxel-cyclophosphamide (TC) regimens. Trial details. Participants in this study will be randomly (by chance) divided into one of two groups – exercise or usual care. Participants in the exercise group will attend a supervised exercise program for the duration of chemotherapy treatment. The exercise program involves resistance (i.e. lifting weights) and aerobic exercise (e.g. walking, jogging, cycling) undertaken 2 times per week in an exercise clinic. Exercise sessions will take approximately 60 minutes and will be conducted in small groups under the supervision of an accredited exercise physiologist. Participant in the usual care group will maintain usual care throughout their chemotherapy treatment. These participants will be offered participation in the supervised exercise program at 3 months after the completion of chemotherapy. Assessments will be conducted at baseline (7-10 days before chemotherapy), post-chemotherapy (7-10 days after final chemotherapy administration) and follow-up (3 months post-chemotherapy).
Trial website
http://www.ecuhealthwellnessinstitute.org/research-activity/projects-open-for-enrolment/preventing-chemo-brain-can-exercise-mitigate-chemotherapy-induced-cognitive-impairment-in-breast-cancer-patients
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45434 0
Dr Prue Cormie
Address 45434 0
ECU Health and Wellness Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 45434 0
Australia
Phone 45434 0
+61 8 6304 3418
Fax 45434 0
Email 45434 0
p.cormie@ecu.edu.au
Contact person for public queries
Name 45435 0
Dr Prue Cormie
Address 45435 0
ECU Health and Wellness Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 45435 0
Australia
Phone 45435 0
+61 8 6304 3418
Fax 45435 0
Email 45435 0
p.cormie@ecu.edu.au
Contact person for scientific queries
Name 45436 0
Dr Prue Cormie
Address 45436 0
ECU Health and Wellness Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 45436 0
Australia
Phone 45436 0
+61 8 6304 3418
Fax 45436 0
Email 45436 0
p.cormie@ecu.edu.au

No information has been provided regarding IPD availability
Summary results
No Results