None listed
Conditions
Brief summary
Breast cancer affects 1 in 11 women. Aromatase inhibitors, a first-line treatment for the postmenopausal women treated for breast cancer, have improved the prognosis of breast cancer by at least 20%. However, one side-effect is a rapid decrease in bone mineral density. Without an effective intervention to address the osteoporosis, health costs will increase significantly. The aim of the proposed study is to determine whether the decline in BMD induced by use of aromatase inhibitors for treatment of breast cancer can be reversed in postmenopausal women. We will undertake a randomized controlled trial to determine whether high impact exercise prevents loss of bone mineral density more effectively than usual care. Participants in both groups will receive vitamin D and calcium supplements.
Interventions
Exercise programme - exercise training will run for 12 months, 3 x per week for approx 1 hr each session. A trainer will meet women at their local community gym 3 x per week for the first 4 weeks then reducing to once a month for the rest of the year. The program will consist of 5 min warm-up, 25 min high impact exercise using steps (jumping, running, hopping)25 mins resistance exercise in the limbs and trunk using free weights and resistance equipment, and 5 min cool down. * Daily Calcium carbo
Exercise programme - exercise training will run for 12 months, 3 x per week for approx 1 hr each session. A trainer will meet women at their local community gym 3 x per week for the first 4 weeks then reducing to once a month for the rest of the year. The program will consist of 5 min warm-up, 25 min high impact exercise using steps (jumping, running, hopping)25 mins resistance exercise in the limbs and trunk using free weights and resistance equipment, and 5 min cool down. * Daily Calcium carbonate (1200mg) and vitamin D (1000 IU) supplements
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women will be included if they : Are postmenopausal, based on age, menses history, and/or surgery. Have stage I-III breast cancer. Have oestrogen receptor and/or progesterone receptor positive breast cancer. Have commenced taking aromatase inhibitor within 10 weeks. Have Eastern Collaborative Oncology Group performance status <=2 (Oken et al, 1982). Are sedentary.
Exclusion criteria
Women will be excluded if they have: Any clinical or radiological evidence of distant spread of disease. Taken any HRT within the past 12 months. Taken bisphosphonates within the past 6 months. Received prior treatment with continuous systemic glucocorticoids within the past 6 months. Current treatments with any drugs known to affect the skeleton (eg Calcitonin, calcitrol, mithramycin or gallium nitrate). A history of diseases that influence bone metabolism, such as Paget's disease or ongoing thyroid toxicosis. Previous or concomitant malignancy (apart from breast cancer) within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
Outcome results
None listed