ANZCTR search results

Following the achievement of deep molecular response on tyrosine kinase inhibitors (TKIs) 54 around half of patients with chronic myeloid leukemia (CML) can discontinue TKI and remain in 55 treatment-free remission (TFR). The ALLG CML8 study commenced in July 2006 and enrolled 40 patients with undetectable BCR-ABL1 mRNA (approximately MR4.5 56 ). Molecular relapse was 57 defined as detectable BCR-ABL1 at any level on two consecutive tests or a single value >0.1%. 58 With a median follow-up of 8.6 years (range 5.7-11.2 years) 18 patients remain alive and in TFR 59 (45.0%; 95% confidence interval 31.9% - 63.4%). The latest relapse that occurred was at 27 60 months after stopping imatinib. No patient progressed to advanced phase CML. Twenty-two 61 patients met the criteria for imatinib re-treatment and all regained undetectable molecular 62 response. Twelve of these patients attempted TFR a second time after a median 5.9 years re63 treatment, and 5/12 patients had restarted TKI at last follow-up. Nine patients in long-term TFR 64 were additionally monitored by highly-sensitive BCR-ABL1 DNA PCR in a sufficient number of 65 samples to enable more precise quantification of residual leukemia. The level of BCR-ABL1 DNA decreased from a median of MR5.5 in the first year of TFR to MR6.2 66 in the latest 3 years of TFR. 67 Our results support the long-term safety and remarkable stability of response after imatinib 68 discontinuation in appropriately selected CML patients. Furthermore, serial high sensitivity testing 69 provides a new and unexpected finding: that the level of residual leukemia steadily declines in 70 patients in prolonged TFR

The purpose of this study is to examine the genotypes of ABCB1 (a type of gene found in your cells) in a larger group of patients to test whether the correlation (matching of genes with more side effects from drug treatment) seen in the previous small study are true. The primary (main) endpoint will be a correlation of ABCB1 genotype and imatinib dose after three months of therapy that will allow for dose adjustments based on toxicity (side effects). The larger patient numbers will also allow a haplotype (gene) analysis to be done. The importance of dose individualisation is illustrated by studies that show better outcomes for cancer patients who have post-treatment dose adjustments based on therapeutic drug monitoring or on toxicity. However, with these methods, the optimum dose for each patient is often not reached until after the majority of the treatment course has been given. A correlation between ABCB1 genotype and toxicity-adjusted dose has practical significance since a simple blood test could allow effective dose selection in individuals. Approximately 300 patients will be required.

All staff and patients will be blinded from allocation of active agent/placebo. Only authorised clinical trial pharmacy staff will have access to this information. If a medical emergency requires unblinding, the principal investigator is required to provide authorisation for clinical trial pharmacy staff to unblind.

This study will explore the potential of synbiotic combination of probiotic bacteria and resistant starch (RS) to improve health and reduce the risk of colon cancer. Participants will be asked to include in their diet either resistant starch or a probiotic or a combination of the two. Markers of the health value of these dietary agents will then be examined in samples of faeces, blood and samples taken from the lining of the bowel wall. Since the greatest risk of CRC is due to lifestyle (in particular diet) rather than genetic predisposition (family/hereditary bias), defining the disease mechanism and finding ways to prevent its occurrence are of significant importance. The proposed study will help provide valuable information on how resistant starch can be used to improve colon health, provide data on the prebiotic use of resistant starch and detailed information on a “synbiotic formulation” that is already on the market. The study participants (subjects) and the data analyst will be blinded. The probiotic bacteria will be in the form of boxes of capsules labelled - B The resistant starch will be in powder form in sachets labelled - A The combination will be A + B The resistant starch placebo will be labelled - C The placebo probiotic will be labelled - D Example: Pt 1 will be allocated with First 4 weeks A+B, then A and then final 4 weeks B Their boxes and sachets will be labelled A+B, A+D & B+C respectively.

This interventional study will assess the effects of a moderate caloric restriction and progressive exercise prior and during In vitro Fertilization in overweight / obese infertile women on treatment outcomes.

An independent contractor will fill and label the vials. The capsules and vials between medicine and placebo will be identical. Each vial will have a unique identifier which will allow the data to be properly decoded at the conclusion of the study. The patient and the physician/hospital staff, etc will be blinded.

Therapeutic options for patients with metastatic colorectal cancer whose cancers have progressed after treatment with standard therapies are limited. Cetuximab therapy is a new treatment targeting the epidermal growth factor receptor (EGFR, a protein on the surface of many cancer cells). Cetuximab can attach to this protein and may stop cancer growth. This study will examine the effect of cetuximab on length and quality of life in people with advanced EGFR positive colorectal cancer whose cancer has progressed after chemotherapy.

The purpose of the study is to investigate whether patients who receive a copy of the psychiatric assessement letter that is sent to their GP have improved adherence to treatment recommendations. There are two hypotheses: 1. receiving the assessment report will improve patient adherence to treatment recommendations; 2. that receiving the assessment report will improve patient outcomes.

BACKGROUND It is speculated that involvement of Palliative Care teams with patients in the Intensive Care Unit (ICU) receiving end-of-life care may lead to better patient, family, and staff satisfaction with the care provided in the ICU, but this has not been studied before. Palliative Care teams have been shown to improve many measures of outcome, such as symptom control, patient and family or carer satisfaction, and health care costs in several other medical settings. AIM The aim of this study is to examine the effect that the Palliative Care team has on outcomes in patients receiving end-of-life care in the ICU. HYPOTHESIS Our hypothesis is that the involvement of the palliative care team in patients receiving end-of-life care in the ICU improves patient and staff quality indicators for end-of-life care. RESEARCH PLAN This pilot study is a single centre, unblinded, prospective, randomised, controlled trial in patients in the ICU, in whom the treating doctors believe that the current medical condition is terminal or pre-terminal, and that treatment should either be withdrawn or not escalated. Patients will be eligible for the study, if they suffer from a terminal or pre-terminal condition, and if the treating ICU physician, in consultation and agreement with the treating parent team, deems it appropriate for end-of-life care to be started, and deems it appropriate that current treatment either should have limitations imposed and should not be escalated, or should be withdrawn or withheld. Enrolment will begin after the treating ICU consultant has discussed the medical issues with the patient and/or their family and has indicated that it is their professional belief that treatment should not be escalated and palliative care should be instituted. Enrolment will be via direct approach from research staff. Consenting patients will be divided randomly into 2 groups. The control group will have usual, standard ICU care. The study group will have usual, standard ICU care, and in addition, a Palliative Care Team will consult. Consenting families will be asked to complete 2 questionnaires; one soon after the initial enrolment discussion, and a second questionnaire after the patient's death or transfer out of the ICU. Medical and nursing staff will also be asked to complete similar questionnaires. The questionnaires will ask questions on several quality indicators for end-of-life care, such as communication, continuity of care, emotional and practical support, symptom management, decision making, and other aspects of support. As outcome data is currently unknown, a blinded analysis will occur after 40 patients have been enrolled to determine the sample size required for significance. We intend to enrol 180 patients, in line with our current predictions for statistical significance. Analysis will be on intention to treat. Non-parametric testing will be used to analyse differences between the two groups. This study is a 3 year pilot study, with the aim of constructing a larger, multi-centre trial after completion. OUTCOMES AND SIGNIFICANCE The primary outcomes will be composite scores for patient/family satisfaction with care in the ICU, composite scores for staff satisfaction with care in the ICU, and length of ICU and hospital stay. End-of-life care in the ICU is currently a significant problem in Australia. With the change in philosophy in medical care from paternalism to consumerism, many patients are now demanding expensive, but futile medical care. Many patients receive treatment and organ support, not because the treatment is indicated, but for other reasons. Palliative Care has been shown to improve end-of-life care in many areas outside of ICU, and has also been shown to reduce health care costs in these areas. We expect this study will be significant in demonstrating that Palliative Care teams can help improve end-of-life care outcomes, and reduce health care costs in the ICU.

Joint Hypermobility Syndrome is a common but poorly recognised condition which mainly affects children. Joint hypermobility or double-jointedness can result in significant symptoms of pain, often described as growing pains, and symptoms of fatigue. This research study aims to find out what the best set of physiotherapy exercises is to reduce knee pain in individuals with joint hypermobility and pain. We are looking to recriut 40 teenagers aged 12-16 with knees that bend backward and are sore and give them 8 weeks of physiotherapy to see if it helps with the pain. Physiotherapy is the recommended treatment in this situation but reaserch to prove that it works has never been done, also different hospitals recommend different types of physiotherapy exercises and we will try and find out which ones work best or if there is no difference.