ANZCTR search results

This randomised clinical trial will compare the combination of three cycles of chemotherapy (CMF) followed by tamoxifen versus tamoxifen alone in postmenopausal patients with node negative, oestrogen receptor positive breast cancer to determine which therapeutic strategy is better in terms of disease-free survival, overall survival and quality of life.

Background: 15,000 people are admitted to an Intensive Care Unit in Australia with severe sepsis every year. One third of these patients will die. Severe sepsis occurs when an infection causes dysfunction of one or more of the major organs (such as the heart or kidneys). A significant factor in this illness is that the body's normal response to infection or'inflammatory response' becomes abnormal. The statins are a class of medications commonly used in Australia to lower cholesterol. Previous research suggests that they may also have a beneficial effect on inflammation and that it may be harmful for people who are already taking statins to stop taking them if they develop severe sepsis. There is a lack of current information on the effects of these drugs in acute illness and the risks and benefits of continuing or starting treatment with them in patients with severe sepsis in the ICU. The aims of this project are: To assess the safety profile of atorvastatin in patients with severe sepsis To assess the effect of atorvastatin on inflammation and the outcome of patients with severe sepsis Research Design: A randomised controlled trial of atorvastatin 20mg versus placebo. Methods: Patients in the ICU with severe sepsis who meet the entry criteria will be given 20 mg of atorvastatin (a commerically available medication) or a placebo ("dummy drug"). The study drug will be given as a capsule by mouth or the contents will be given mixed with water via a feeding tube. Drug will be given once per day while the patient is in the ICU to a maximum of 28 days. Safety blood tests to look for signs of liver or muscle damage will be taken every day. Additional blood tests to assess inflammation will be taken 6 times during the study. All other care will be given as standard care.

Pilot studies show that spironolactone is effective in the arrest of female pattern hair loss and may result in some hair gain. However to date there have been no placebo controlled trials to verify this. As well minoxidil has been shown to be efficacious in the treatment of female pattern hair loss and there are recent case reports that it may have a synergistic effect when used with spironolactone. This project aims to study the effectiveness of these treatments as well as determining underlying tissue and genetic factors that may effect response.

The aim of the study is to test the effects of a couple based education program (Couple CARE for Parents) with couples having their first baby. We will assign couples to receive Couple CARE for Parents or usual woman focused education and support. We predict that Couple CARE for Parents will enhance couple relationship satisfaction, individual adjustment and parenting.

This clinical trial is for premenopausal and young postmenopausal women who after their breast cancer surgery have been found to have cancer cells in the glands of the armpit (‘positive axillary lymph nodes’) and whose tumours do not have oestrogen receptors (are not stimulated by oestrogen). These tumour characteristics are often associated with a higher risk for breast cancer recurrence. It is known that chemotherapy in standard doses after breast cancer surgery reduces the chance of breast cancer recurrence. However, this clinical trial aims to assess whether giving higher doses of chemotherapy is more effective in killing remaining cancer cells in women with a high risk of recurrence. Women will be allocated randomly (like the toss of a coin) to have either standard chemotherapy for their breast cancer, or high dose chemotherapy.

It is unclear whether patients who do not undergo an axillary dissection and receive further systemic treatment, have a similar prognosis to those with axillary clearance who receive the same therapy. The focus of this international trial is to determine the importance of an axillary node dissection for breast cancer patients 60 years or older who receive Tamoxifen as an ongoing treatment. Particular attention will also be given to the quality of life of the patients over the first six years of the study.

The use of tamoxifen has provided a reduction in deaths due to breast cancer in postmenopausal women with both node-positive and node-negative disease. However, the benefit of tamoxifen treatment may be confined to patients with oestrogen receptor positive disease and a standard adjuvant treatment for all postmenopausal patients with node-positive, oestrogen receptor negative disease has not yet been defined. Results from previous trials have indicated that the combination of CMF and tamoxifen (chemo-endocrine therapy) improved disease-free survival in all postmenopausal patients when compared with CMF or surgery alone. Patients with oestrogen receptor negative disease were found to benefit significantly from the combined treatments. Therefore, IBCSG VII will investigate the effectiveness of adding early combination chemotherapy and late additional chemotherapy to adjuvant tamoxifen compared to administering tamoxifen treatment alone in postmenopausal women.

The optimal duration of adjuvant chemotherapy in premenopausal patients with operable early stage breast cancer is currently unknown and it is thought that relapse of disease following adjuvant therapy may be due to the presence of cells which are non-responsive to first cycles of treatment. Therefore, IBCSG VI will investigate whether 3 cycles of initial adjuvant chemotherapy are as effective as 6 cycles and whether the addition of 3 cycles of chemotherapy after a treatment-free interval is as effective as administering an initial course of chemotherapy alone in premenopausal patients.

This study plans to investigate whether statements made during intravenous induction of anaesthesia with propofol affect the perception of pain on injection.

This study will use the best quality research methods to test whether providing a 6-month individualised exercise and nutrition program to hip fracture patients soon after injury improves walking and other important health outcomes. Patients will be followed for 12 months to determine what difference the exercise and and nutrition programs make. If they help then health services will have the evidence they need to recommend this type of program to the growing number of older Australians that suffer a hip fracture.