ANZCTR search results

The Sentinel Node versus Axillary Clearance (SNAC) trial was the first, large, Australasian prospective assessment of the risk of lymphoedema after surgery for early breast cancer. The trial compared sentinel node biopsy of selected lymph nodes with clearance of axillary nodes in women with tumours smaller than 3 cm. Short-term results showed that arm swelling was less in the group having only sentinel node biopsy. Both treatment groups had moderate limitations in arm movement over the first 6 months, which then recovered to near normal levels. The results showed that for women with small tumours, sentinel node biopsy was a viable alternative to axillary clearance. The patients are being followed up so that long-term effects can be measured. Outcomes at 3 years will shortly be published. In SNAC 2, the investigators are recruiting women with large or multiple tumours in a more extensive trial with similar questions, which will allow any differences in subgroups of women to be analysed.

The primary purpose of this study is to assess the safety and tolerability of subcutaneous doses of ACV1 in healthy adult males.

This substudy is an open-label, randomised study comparing the uptake of rIL-2 in HIV-1 infected individuals receiving different combinations of antiemetics and analgesic agents during rIL-2 dosing in ESPRIT. The design is a factorial one with 4 arms, all patients will receive regular ibuprofen and paracetamol from days 1-6 of the rIL-2 dosing cycle in addition, patients will be randomised to receive one of two antiemetic combinations i.e. ondansetron or metoclopramide with or without low dose codeine phosphate as an additional analgesic agent.

A randomised, double blind, placebo controlled trial was conducted over 42 weeks using parallel groups of individuals with prospectively confirmed mild to moderate premenstrual tension. The primary outcome measure was the Premenstrual Symptom Score (PMSS) assessed by questionnaire. Women were initially enrolled based on the Menstrual Health Questionnaire results taken at baseline. They then completed the assessment instrument each day for 2-3 menstrual cycles. Subjects were then excluded if they did not demonstrate a 30% increase in premenstrual symptoms between the follicular and luteal phases of 2 consecutive cycles. Only subjects meeting these criteria were randomised for the intervention phase. The treatment arms were 1) Swisse Ultivite for Women and 2) placebo. Minimal side effects were reported during the treatment period. Initial consideration of the data pertaining to liver, renal and hemopoietic function showed no clinically significant changes. There were significant reductions in premenstrual syndrome symptoms between the pre-treatment and post treatment stages of the study for both the placebo and active treatments.

Each year approximately 10,000 women are diagnosed with breast cancer in Australia, making this the most frequently diagnosed cancer in reproductive age women. Approximately 6-7% of these women are under 40 years at the time of their diagnosis. All patients faced with decisions about treatment for cancer need to weigh up the benefits and side-effects of treatment. This issue is particularly relevant in considering the effects of treatment on future fertility. The prognosis in terms of survival for young women is often excellent, but permanent ovarian failure and hence infertility as a result of adjuvant chemotherapy is a common consequence. For many young women, this is of enormous importance. Yet, many are not fully informed of the potential adverse reproductive effects of chemotherapy or fail to take in the possible consequences of treatment while making treatment decisions shortly after the diagnosis of breast cancer. Our objective is to conduct a comprehensive nation-wide prospective study to compare the efficacy of a fertility-related decision aid (an information tool specifically designed to assist with decision-making) to usual care amongst young women with early breast cancer. The decision aid will present information on choice of chemotherapeutic agents, Assisted Reproductive Technology (ART) options and the impact of pregnancy following diagnosis on prognosis. Following pilot-testing, the decision aid will be tested in a prospective nationwide study involving 17 oncology clinics, and young women with early breast cancer will be recruited prior to commencement of any adjuvant therapy. Data will be collected prior to commencement of adjuvant therapy, and 1 and 12 months following this, using self-administered questionaries assessing a range of variables, using validated measures of psychological and decision-related outcomes.