ANZCTR search results

This Phase IIa trial will assess the safety and tolerability of a topical gel containing 1% R-flurbiprofen, when applied to the skin of subjects with a history of non-melanoma skin cancer. This will be a double-blind, randomised, placebo-controlled trial. All subjects and study personnel will be blinded, except for the person allocating the active or placebo tubes to each subject, based on the randomisation schedule. Thirty subjects will receive the R-flurbiprofen gel, and 10 will receive a placebo gel. The gel will be applied topically once daily, for 28 consecutive days, to the face, ears, neck, forearms and hands. The primary outcome measure will be skin irritation at the site of gel application. Lay statement: This trial will test the safety of a gel when applied to the skin of people who have had at least one non-melanoma skin cancer. A future trial will test if this gel can prevent, or reduce the occurrence of, non-melanoma skin cancer.

The ANZ 0502 (Neo Gem) clinical trial is conducted by the Australian New Zealand Breast Cancer Trials Group (ANZ BCTG) in a number of hospitals in Australia and New Zealand. The trial is for women with newly diagnosed large operable breast cancer or locally advanced breast cancer - which often involves the lymph nodes under the armpit (axillary nodes). Larger operable and locally advanced breast cancers are associated with a poorer prognosis and higher risk of micometastatic disease. Standard treatment for this type of breast cancer usually includes chemotherapy to try to reduce the size of the cancer, followed by surgery and radiation therapy to treat any remaining cancer in the breast. Whilst this treatment is successful in removing the cancer from the breast in the majority of patients, there is a significant risk of the cancer recurring. The treatment in this trial will involve a course of standard chemotherapy (epirubicin and cyclophosphamide) followed by a course of two newer chemotherapy drugs for breast cancer (docetaxel and gemcitabine), followed by surgery. The delivery of chemotherapy prior to surgery offers the potential to substantially reduce the size of primary breast tumours and allow for breast-conserving surgery or surgical resection of previously inoperable tumours. It is hoped to also reduce the risk of recurrence of the breast cancer. The trial includes provision for patients with breast cancer tumours which overexpress HER2, by adding trastuzumab (Herceptin) to the docetaxel and gemcitabine (DGH) treatment cycles in order to maximise the efficacy of all three agents.

Hot flushes are frequent and bothersome to many women previously diagnosed with breast cancer. Fatigue, insomnia, anxiety and mood problems are often related to hot flushes. According to the literature a psycho-educational intervention seems to be a promising treatment for hot flushes but has not been rigorously studied in women with previous breast cancer. The primary purpose of the study will be changes in frequency of hot flushes and daily hot flush score (frequency x severity score for each HF). Hypothesis: A psycho-educational intervention utilising information provision, cognitive behavioural strategies and relaxation training will improve hot flushes, fatigue, insomnia, anxiety and mood disturbance in women with previous breast cancer. The psycho-educational intervention will involve four weekly group sessions during which information about hot flushes and related symptoms (insomnia, fatigue, anxiety and mood problems) will be given. We will also give strategies to improve and manage these symptoms according to some cognitive-behavioural strategies. In addition relaxation techniques will be taught to try to reduce the frequency/severity of hot flushes.

A Very Early Rehabilitation Trial (AVERT) Randomised controlled trial of very early mobilisation (intervention) versus standard care (control) with blinded assessment of outcome and intention to treat anlaysis. A comprehensive cost eccectiveness sub study is included. It is hypothesised that early mobilisation of patients in addition to standard care alone, will reduce death and disability at 3 months, reduce the number and severity of stroke complications experienced by patients, resullt in a better quality of life and is cost effective.

Prostate cancer is the most common serious cancer in Australian men. Radiotherapy is a common treatment for prostate cancer, which can result in distressing side effects, including urinary and bowel urgency or incontinence (35%), and erectile dysfunction (41% to 55%). These are complex and often chronic conditions, which can adversely affect the patient's quality of life and psychological morbidity. Men with prostate cancer also experience high unmet needs, particularly in relation to sexuality. This research aims to examine the effectiveness of a multi-disciplinary care (MDC) program incorporating consumer involvement to reduce psychological morbidity, unmet needs and improve quality of life in men receiving radiotherapy for prostate cancer using a randomised controlled trial (RCT). 400 men will be recruited and complete baseline measures before being randomised to receive the psycho-educational intervention or usual care. The intervention will comprise of four, 1-hour group consultations led by a clinical nurse consultant, and one individualised nurse session. The consultations occur at critical moments in the illness trajectory: pre-treatment, mid-treatment, end of treatment and 6 weeks post-treatment. The focus of these sessions will be to share common concerns, ask questions and receive information. The content of sessions are tailored to patient concerns. Follow up questionnaires will be administered at the end of treatment, and 6 months post-treatment. The program will be evaluated by comparing results for the control and intervention groups on measures for anxiety and depression, unmet needs, quality of life, distress and preparation for cancer treatment.

While patients with advanced cancer have high levels of unmet needs, a recent systematic review indicated that very few trials of psychosocial interventions have been conducted with palliative patients, and none have been conducted with lung cancer patients. The present research aims to evaluate a supportive care program for patients with inoperable lung cancer who have a potentially limited life expectancy, using a randomised controlled design. 210 patients will be recruited and asked to fill out baseline measures of anxiety/depression, unmet needs and quality of life. Participants will then be randomised to receive either the intervention or usual care. Permission will be sought from participants to obtain information about medical variables from their medical record. Oncologists will provide information about each participant’s treatment plan, performance status, and awareness of prognosis, and will refer intervention participants to two supportive care sessions. Participants will be encouraged to bring a significant other(s) with them to the supportive care sessions. The content of each session will be tailored to respond to needs identified in the baseline data. The first group session will be timed to correspond with the beginning of treatment, and the second will occur at the end of treatment. In addition, baseline data summaries for each intervention patient will be made available to the treating team to assist them in meeting the patient’s needs. Where particular needs are identified, appropriate referrals will be made (e.g. to social work, psychology etc) by the Lung clinical nurse coordinator. Follow-up measures (anxiety/depression, unmet needs, quality of life and needs related to treatment preparation) will be administered at 8 and 12 weeks post baseline when patients attend the clinic at these approximate time points.

Delirium is common in patients with advanced cancer, and presents with symptoms of disturbed sleep, attention, and/or memory; and restlessness or drowsiness. The cause of this is believed to be due to a disturbance of the cholinergic transmitter system in the brain. This could be due to anticholinergic activity of medication, or substances produced in acute illness. It is not possible to measure these abnormalities in the brain in the clinical setting, so a surrogate marker(s) that is routinely measured would be useful. A serum anticholinergic assay can quantify anticholinergic activity in the blood. We aim to measure this on admission to a palliative care unit, and at an episode of delirium, and look at its levels in relation to its ability to predict the occurrence of delirium. We will also look for associations with other simple clinical and investigational measures, so a model can be developed to more accurately predict those at risk of delirium so preventive strategies and early identification can be utilised.

New approaches to the treatment of advanced oesophago-gastric cancer are likely to involve biologically relevant targets, which either alone or in combination with chemotherapy, may result in prolonged disease stabilisation or tumour response, hence improving patient outcomes (QOL, symptom control and survival). One such biological target is the epidermal growth factor receptor (EGFR). The role of EGFR in advanced oesophago-gastric cancer is unknown although high EGFR expression is known to occur in around 60-80% of patients and is associated with an adverse prognosis and resistance to chemotherapy. Furthermore, responses have been observed using agents targeting EGFR in advanced oesophago-gastric cancer. Cetuximab is a well-characterised, relatively non-toxic antibody directed against EGFR. Cetuximab has been used as a single agent and in combination with chemotherapy in a variety of cancers. Hence it seems appropriate to examine the role of cetuximab in advanced oesophago-gastric cancer. Considering the fact that docetaxel based regimens appear highly active in advanced oesophago-gastric cancer, there is a strong rationale for combining docetaxel with cetuximab. Synergy between taxanes and other agents targeting the family of EGFRs has been observed in other types of cancer. Therefore we have developed this Phase II study of cetuximab plus docetaxel in patients with advanced (recurrent or metastatic) oesophago-gastric cancer who are refractory to docetaxel therapy. This is an optional extension study for patients who have participated in ATTAX (AG0603) (all of whom receive docetaxel) and who have progressed either during or within 6 months of docetaxel based chemotherapy.

Velcade is a new drug, which is being developed for the treatment of patients with a variety of cancers. In studies to date, it has been shown to be useful in the treatment of patients with advanced multiple myeloma whose myeloma has progressed after standard drug treatment. Approximately one third of them have had a response to treatment, which has lasted for approximately 12 months. It has been associated with improvement in symptoms from the disease including improvements in blood counts, fewer blood transfusions and in a lessening of bone pain. There is some evidence that more patients respond to Velcade when it is given together with a steroid drug, Dexamethasone, which is commonly used in the treatment of Myeloma, and you may have received in the past. Only a small number of patients have been treated with Velcade and Dexamethasone from the beginning of therapy. However, many more have had Dexamethasone added later if they have failed to respond to Velcade on its own. Velcade is approved in the USA and Europe by the Food and Drug Administration (FDA) for the treatment of patients with myeloma. However, Velcade is not approved in Australia and therefore its use in this study is considered experimental. This study has two main aims. The first is to assess whether Dexamethasone can increase the number of patients who respond to Velcade in the controlled setting of a clinical trial. This study is specifically designed for patients who have received at least one kind of standard treatment in the past and are now in need of further therapy because their disease has relapsed. The second aim of this study is to see whether treating patients with Velcade and Dexamethasone for a longer period of time extends the time that the myeloma is under control. This is known as maintenance treatment. Approximately 100 patients will participate around Australia.