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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.

The reported incidence of painful Achilles tendinosis is 6-17% amongst adult athletes. This condition results in considerable impairment of training and performance in athletes. To date, evidence suggests that of the treatment strategies investigated, exercise programs that involve mildly painful eccentric contractions of the muscles of the calf are the most effective at reducing pain and improving function for people suffering from this condition. Although the underlying mechanism conferring improvement is unknown, there is now some evidence suggesting a link between the presence of newly formed blood vessels (neovascularisation) and painful tendinosis. With a program of mildly painful eccentric loading exercises, there is a sustained reduction in pain with disappearance of these new vessels. Similar sustained reductions in pain have been shown with prolotherapy injections of hypertonic glucose and local anaesthetic. Prolotherapy involves the repeated injections of an irritant solution with the intention of sclerosing neovessels and stimulating inflammation and subsequently new collagen formation. With respect to Achilles tendinosis, the relative efficacy of these two approaches, individually and in combination, has not been tested. This project aims to conduct a pilot randomised clinical trial comparing prolotherapy injections eccentric loading exercises singly and in combination. It will be conducted in research clinics to be set up at Logan and in Christchurch, New Zealand. It will be a single blinded trial with the assessor being the blinded person. Experience and information from this pilot trial will be used to inform an adequately powered randomised clinical trial of prolotherapy injections and eccentric loading exercises for painful Achilles tendinosis.

The purpose of this project is to test a new way of providing patients with information about chemotherapy. Previous experience has shown that many patients feel anxious before starting chemotherapy treatment, and would like the opportunity to discuss their concerns about treatment, treatment related side effects and ask questions. Patients will be randomly allocated to receive either the usual chemotherapy education program or the new chemotherapy education program we are testing. The two groups will be compared on measures of psychological distress, symptoms/side effects of chemotherapy, confidence in dealing with side effects of chemotherapy and unmet needs.

40 patients with COPD are randomly allocated to either receive a four session preventative CBT intervention, or not receive this intervention in addition to usual treatment. Subjects are then followed up every six months for 18 months to investigate the efficacy of the intervention in preventing the development/worsening of panic anxiety symptoms.

The aim of this project is to evaluate the effectiveness of reducing painful callus (hard skin) on the bottom of the feet (using scalpel debridement) versus no reduction (using a sham debridement technique). This study is double-blind: both the participants and the assessors will be blinded.

The aim of this study is to determine the effect of extended therapeutic contact over a 2 year period on a community-based weight management group program in overweight and obese young people aged 13-16 years. The additional therapeutic contact, via phone coaching, e-mail and SMS messages, is designed to give each young person the extra support and guidance to empower them to make and maintain healthy lifestyle changes. 168 young people will be randomised into either the group program, or the group program plus extended therapeutic contact. They will be followed up for 2 years to assess the effect of the program on a variety of health outcomes including weight, self-esteem and metabolic health. Adolescents’ height, weight and waist circumference will be measured at baseline, 12 months and 24 months by contract staff who are blinded to treatment allocation. In addition, adolescents will be asked not to reveal their treatment allocation to staff who perform the measurements. Of course, it will not be possible for the adolescents to be blinded to treatment allocation. If effective, we expect the following outcomes: 1) A reduction in levels of overweight and obesity in young people aged 13-16 years 2) The adoption and maintenance of healthy lifestyle behaviours in that segment of the population which has most to gain over a lifetime - overweight and obese young people 3) A novel, replicable, feasible, cost-effective community-based approach to overweight and obesity in young people tailored to the Australian health care system

The purpose of this study is to investigate the effect of a 6-week patient education program, the Arthritis Self-Management Program, for people with hip or knee osteoarthritis. This study will find out whether the Program improves people’s wellbeing and whether it is good value for money.

Many people who acquire a brain impairment (e.g. through stroke or traumatic injury) suffer significant paralysis and loss of function in their arms and hands. This loss of function is extremely disabling and effects many aspects of their daily lives. Therapists frequently provide motor retraining programs to try and help them regain functional use of their limbs. Unfortunately, there is considerable variation in the type and amount of therapy given. Current evidence also suggests that many of these patients do not regain their function despite participating in therapy. This randomised controlled trial will attempt to determine if an intensive daily program of specific functionally based hand exercises is able to improve the hand function of people with acquired brain impairment. It is hoped that its results will help to guide the current and future practice of Occupational and Physiotherapists working in rehabilitation. Final measured outcome assessor of the study is blinded.

Health professionals working with people with haemophilia and other bleeding disorders (PWH) report a concern that patients appear to be at increased risk of falls and serious injuries from falls. However, to date there is no published research about falls risk in samples of adult haemophilia patients or any research quantifying the extent of balance dysfunction in PWH. Therefore this project aims to: - Determine which measures of balance performance are most useful in identifying balance impairment in PWH in comparison to healthy age and gender matched controls; - Evaluate the association between balance performance and falls risk; - Evaluate the association between balance performance and falls efficacy (confidence in mobility); and - Evaluate the feasibility and effectiveness of a tailored home exercise program in improving balance and related outcomes for PWH. Thirty adults with haemophilia or other bleeding disorders and 30 age and gender matched healthy adults will be recruited. All participants will undergo a baseline assessment of laboratory measures of balance, clinical measures of balance, falls risk, falls efficacy, activity level, pain, disease severity and health related quality of life. Following the initial assessment the participants from the haemophilia group will be provided with an individually tailored balance and strengthening home exercise program from a physiotherapist, based on the results of the initial assessment. The participants will be required to undertake the home exercise program for four months, during which time they will receive two visits from the physiotherapist, who will review them and provide any support required. At the end of the four month program the participants from the haemophilia group will undergo the baseline assessment again in order to evaluate their progress. This pilot work will be useful to inform health care providers, and PWH, about the magnitude of the problem of balance dysfunction, what methods are most appropriate to identify this risk, and whether standard balance training exercises will be useful in this group. If successful, further studies will be required with a large sample to evaluate whether this approach can reduce falls in this group.