ANZCTR search results

Co-morbid depression and anxiety are becoming a critical issue in the management of alcohol dependence due to the high prevalence, debilitating effects and lack of effective treatment options. This proposal seeks to generate and evaluate a novel, integrated treatment for comorbid anxiety or depressive disorder. Participants will all receive anti-craving medication (naltrexone and/or acamprosate) and formal assessment of clinically relevant anxiety or depression. They will then be randomized to receive either a usual counselling care or a CBT ‘stepped-care’ intervention including a manual-based psychotherapy appropriate for their psychiatric profile. Participants will be followed up at 3 and 6 months to determine the benefits of integrated treatment on alcohol consumption, comorbid symptoms and health. It is hypothesised that stepped care for alcohol dependence with comorbid mood or anxiety disorders will result in less relapse and lower alcohol consumption compared to usual care, and result in a greater improvement in comorbid symptoms and quality of life compared to usual care.

Menopausal symptoms are common in women treated for early breast cancer. Hormone replacement therapy (HRT) is very effective at relieving menopausal symptoms, but we do not know if HRT is helpful or harmful for women who have had breast cancer. This trial will determine the effects of HRT in women who have been treated for early breast cancer. The trial aims to include 1300 women from around the world who will be treated with either HRT or the best non-hormonal alternative treatment while being closely monitored by their cancer specialists and gynaecologist.

IBCSG VIII is a randomised clinical trial designed to test the therapeutic role of short duration ovarian function suppression (using Zoladex) in pre-/perimenopausal patients with node negative breast cancer.

The study aims to determine whether a brief, primary-care behavioural intervention, designed to manage infant sleep problems, can improve both infant sleep and symptoms of maternal depression. Up to 45% of parents report a problem with their infant’s sleep in the second six months of life whilst up to 15% of Australian mothers are affected by postnatal depression. There is a strong link between infant sleep problems and postnatal depression. This intervention has the potential to reduce the twin burdens of both sleep problems and postnatal depression and therefore significantly improve the wellbeing of mothers, their children and their families.

This clinical trial is for premenopausal women who after their breast cancer surgery are found to have breast cancer which is not suitable for hormonal treatment alone, and who also have cancer cells in the glands of the arm pit ('positive axillary lymph nodes’). It is known that these women will benefit substantially by having chemotherapy after surgery for breast cancer. The optimal chemotherapy program involves two short courses of different chemotherapy programmes (AC [doxorubicin or epirubicin + cyclophosphamide] & CMF [cyclophosphamide, methotrexate, 5-fluorouracil). It is not known whether the second chemotherapy course (CMF) should begin immediately after the first course (AC) or whether it should be delayed with a break in between. Whether or not a patient will have a gap between her chemotherapy programmes, as well as whether she will have Tamoxifen or not will be allocated by a process called randomisation which is similar to tossing a coin. This trial will test whether the delay between the chemotherapy courses is needed as well as if there is an extra benefit of adding a hormonal treatment to the chemotherapy.

This clinical trial is for post and perimenopausal women who after their breast cancer surgery are found to have breast cancer which does not contain hormone receptors (is not stimulated by hormones), and who also have cancer cells in the glands of the arm pit (‘positive axillary lymph nodes’). It is known that these women will benefit substantially by having chemotherapy after surgery as well as long term hormonal treatment for their breast cancer. The optimal chemotherapy program involves two short courses of different chemotherapy programmes (AC & CMF). It is not known whether the second chemotherapy course (CMF) should begin immediately after the first course (AC) or whether it should be delayed (with a break in between). Whether or not a patient will have a gap between her chemotherapy programmes will be allocated by a process called randomisation which is similar to tossing a coin. This clinical trial will assess which method of giving chemotherapy is optimal for decreasing the chance of breast cancer recurrence and increasing patient survival.

At present, it is standard for women with early breast cancer to receive five years of treatment with tamoxifen, following surgery. For many women, tamoxifen reduces the risk of breast cancer returning. However, some information suggests that tamoxifen may be of most benefit in the two to three years after surgery, after which it becomes less effective. The Adjuvant Exemestane trial will test whether it is better to take five years of tamoxifen, or to begin a new treatment (exemestane) after two to three years of tamoxifen, for the remainder of the five years. Exemestane is effective in patients with advanced cancer who have already been treated with tamoxifen and had their cancer return. Internationally, 4400 postmenopausal women who have had early breast cancer and taken two to three years of tamoxifen treatment will take part in the trial, and be given either exemestane or more tamoxifen to finish five years of treatment. It is hoped that switching treatments will be more effective at lowering the risk of breast cancer returning than continuing tamoxifen, and it may also lower the risk of developing long-term side effects from tamoxifen.

Approximately 20-30% of women with advanced breast cancer have a genetic alteration in the HER2 gene (human epidermal growth factor receptor-2), causing an over-expression of the HER2 protein in the tumour, which is associated with a more aggressive disease and a worse prognosis. Patients with this type of breast cancer benefit from treatment with Herceptin when the patient has not previously received chemotherapy for their advanced disease. This randomised clinical trial evaluates the use of Herceptin in combination with currently available chemotherapy treatments in providing a better outcome for these patients by delaying progression of the cancer and death with as little toxicity as possible. The trial will compare two treatments: (1) a combination of the drugs Taxotereâ, platinum salt and Herceptinâ and (2) a standard treatment of Taxotereâ and Herceptinâ in combination without platinum salt.

A greater proportion of people with osteoarthritis of the knee who complete the OAK Program will report minimal clinically important improvements in pain, knee function and quality of life, at 8 and 12 weeks, compared with those completing the generic ASMP course.

This study is being conducted in order to determine the proportion of HIV-1 patients attending Holdsworth House Medical Practice that may be susceptible to abacavir hypersensitivity reaction (HSR), which is associated with a genetic marker HLA-B*5701. Abacavir is a drug used in combination with other antiviral drugs, which is helpful in treating HIV infection. Abacavir is generally well tolerated, but 5-8% of patients develop an allergic reaction to the drug and the allergic reaction is much more common in those patients who have the genetic marker HLA-B*5701. Abacavir HSR is an allergic reaction characterised by respiratory and gastrointestinal symptoms that may be life threatening if abacavir dosing continues. Thus avoiding the use of abacavir in patients carrying this genetic marker will reduce the likelihood of developing a potentially serious allergic reaction. The study also aims to set up a model for a Registry where patient HLA-B*5701 results can be entered and made available to doctors who are licensed to prescribe HIV therapies in Australia via a secure password protected system. Ideally the Registry will be web-based, but if this is not feasible, it will be paper-based and managed by a recognised independent body already involved in the HIV field.