ACTRN12614000051640.

Trial name or title	Preventing ‘chemo‐brain’: Can exercise mitigate chemotherapy‐induced cognitive impairment in breast cancer patients?
Methods	RCT
Participants	Breast cancer patients scheduled to receive adjuvant chemotherapy with fluorouracil‐epirubicin‐cyclophosphamide‐docetaxel (FEC‐T) or docetaxel‐cyclophosphamide (TC) regimens, target sample size: 66
Interventions	Combination of resistance (i.e. lifting weights) and aerobic exercise (e.g. walking, jogging, cycling), 2 times/week in an exercise clinic. moderate to high intensity (i.e. a perceived exertion of somewhat hard to hard) and will be relative to each participant's capabilities. Progressive exercise prescription, modified according to individual response. Approximately 60 min/session, small groups under the supervision of an accredited exercise physiologist. Length of program: will vary from 2.5 to 4 months according to the duration of the chemotherapy regimen Control group: usual care
Outcomes	Primary outcome: Cognitive function: Hopkins Verbal Learning Test‐Revised, Trail Making Test, Controlled Oral Word Association of the Multilingual Aphasia Examination. Secondary outcomes: Quality of life: Medical Outcomes Study 36‐Item Short Form Health Survey, Functional Assessment of Cancer Therapy for patients with breast cancer questionnaire Psychological distress: Brief Symptom Inventory‐18 (BSI‐18), Hospital Anxiety and Depression Scale (HADS) Fatigue: Functional Assessment of Chronic Illness Therapy‐Fatigue Neuropathies: Functional Assessment of Cancer Therapy‐Neurotoxicity Musculoskeletal symptoms including myalgias and arthralgias: Muscle and Joint Measure questionnaire Sleep quality: Insomnia Severity Index Physical function: 400‐m walk (aerobic capacity), 1 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 Organization Test (static balance) Physical activity level: Godin Leisure‐Time Exercise Questionnaire
Starting date	June 2014 first participant enrolment
Contact information	Dr Prue Cormie ECU Health and Wellness Institute Edith Cowan University 270 Joondalup Drive Joondalup, WA 6027, Australia
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