ANZCTR search results

Currently, frailty is rarely identified prior to surgery and patients undergoing colorectal cancer surgery do not have prehabilitation optimization at Western Health (WH). Recent investigations of our WH population have identified poorer functional outcomes and lower quality of life associated with this population which indicated unmet psychosocial and occupational performance needs. With this study, we plan to introduce a novel approach to tailored treatment in our most at-risk group of patients. Who is it for? You may be eligible for this study if you are an adult who has a planned surgery for primary colorectal cancer at Western Health. Study details All patients enrolled in this study will undergo a frailty assessment and be prescribed a pre habilitation to be completed over a period of 4 weeks. This prehabilitation program will include nutritional adjustment by a dietician and improvement of exercise function by physiotherapy. Patient quality of life questionnaires, food diary, nutritional and physical fitness assessment will be carried out by dieticians and physiotherapists. It is hoped that this study will show that it is feasible for frail and at-risk colorectal cancer patients undergoing surgery to undergo prehabilitation. This aims to improve strength, mobility and flexibility, reduce frailty, and improve post-operational outcomes such as length of stay.

This research will investigate whether long-term methamphetamine use produces changes to driving ability in the absence of acute intoxication, and whether this can be effectively indexed and monitored through objective markers of performance. Using our high-fidelity driving simulator with advanced simultaneous eye-monitoring technologies, we will use real-time analysis of head position and eye movements to examine the relationship between gaze vector and driver behaviour to better understand the impact of methamphetamine addiction on driving performance in separate groups of 1.) individuals who use methamphetamine and 2) healthy adults who have no history of the use of psychostimulants and have no history of chronic/binge use of psychoactive substances. We expect that there will be a measurable difference in the patterns of eye movements displayed during driving by individuals who use methamphetamine versus those who have no history of the use of psychostimulants or no history of chronic/binge use of psychoactive substances

Peripheral artery disease is an atherosclerotic disease characterised by blocked arteries and impaired blood supply to the legs, which causes muscle pain and limits waking capacity and the ability to undertake daily activities. People with peripheral artery disease may undergo lower limb revascularisation to improve or restore leg blood flow. Supervised exercise is an effective therapy that can improve walking capacity and quality of life in people with peripheral artery disease. Supervised exercise training following lower limb revascularisation can further enhance the clinical outcomes of the revascularisation procedure. This is a randomised-controlled trial which will assess the efficacy of a community-based cardiovascular rehabilitation program versus usual care on exercise capacity and quality of life in people who have undergone lower limb revascularisation for peripheral artery disease. If successful, this trial will lead to improved clinical outcomes for people undergoing lower limb revascularisation for peripheral artery disease. This study will provide crucial knowledge for the inclusion and integration of patients with peripheral artery disease into community-based cardiovascular rehabilitation exercise programs.

The intervention involves placing four miniscrews (two on the maxilla and two on the mandible) which the frameworks will be fitted over, Class III elastics attached to the frameworks will be worn full-time until the skeletal Class III malocclusion is corrected. The aim of this trial is to evaluate the dental and skeletal changes of skeletal Class III patients treated with Bone- and Tooth-borne Maxillary protraction with Miniscrews and Class III Elastics. The null hypothesis is that there will be no dental and skeletal effects of maxillary protraction using miniscrews and Class III elastics, when comparing the pre- and post-treatment situation. The alternative hypothesis is there will be a dental and skeletal effects of maxillary protraction using miniscrews and Class III elastics.

This study aims to assess the effectiveness of a distance-delivered digital health program on improving physical activity self-efficacy among childhood cancer survivors aged 8-21 years, and to explore the barriers and facilitators to program uptake in these participants. Who is it for? You may be eligible for this study if you are aged between 8-21 years of age, you were diagnosed with cancer as a child prior to age 18 years, and you have completed active cancer treatment at least 6 months prior to the time of study participation OR is receiving maintenance therapy. Parents and caregivers of participants will also be asked to participate in interviews after delivery of the program. Study details All participants who choose to enrol in this study will be given access to an online co-designed program that includes evidence-based health behaviour education and physical activity engagement modules. Participants will be able to access the education modules and view physical activity videos at any time over an 8 week period. Participants will also be scheduled to attend up to 5 telehealth/online video consultations with an Accredited Exercise Physiologist. These consultations will be scheduled prior to participants gaining access to the online program, week 2 or 3 of the program (optional), at week 9 post-program completion, at 3-months and 6 months following program completion. Each consultation will be approximately 60 minutes and will be individualised to the participant and will include exercise assessments, health behaviour education, tailored goal-setting, and discussion of participant barriers and facilitators to exercise. Participants will also be asked to attend interviews with the study investigators to describe the aspects of the program that they enjoyed and the parts that they think could be improved upon. Overall participation in this study is anticipated to take up to 9 months. It is hoped this research will determine whether delivery of a physical activity and healthy lifestyle program via a digital platform that is supplemented with online consultations has a positive impact on the physical fitness and lifestyle choices of childhood cancer survivors. If the program is found to have a positive effect on these participants, it may be expanded to a greater number of childhood cancer survivors in the hope that it will improve their quality of life and reduce the development of chronic health conditions.

Prophylactic antiemetic and analgesic oral premedications are frequently prescribed preoperatively to enhance recovery after laparoscopic gastric sleeve resection. However, it is unknown whether these medications transit beyond the stomach or if they remain in the stomach or sleeve resection specimen, thereby negating their pharmacological effects. The purpose of this study is to identify whether age, sex, body mass index, and diabetes mellitus are associated with the presence or absence of oral premedication in the stomach or resected gastric specimen. Who is it for? The study will include adult patients undergoing bariatric surgery. This is a retrospective analysis of patients who underwent laparoscopic gastric sleeve resection who received premedications as part of usual anaesthesia and surgical care. Study details This study will evaluate the presence or absence of oral premedication in the stomach or sleeve resection specimens. The secondary aims will be to to evaluate whether age, sex, body mass index, or diabetes mellitus are associated with the presence or absence of oral premedication in the stomach or resected gastric specimen. Finally, the study will evaluated the association between premedication lead time and the presence or absence of premedication in the specimen. Premedication lead time is defined as the time in minutes from when the premedication tablets were administered orally to when the gastric sleeve was resected. It is hoped that this study will be hypothesis generating and provide valuable data for power calculations for future studies on evaluating the timing of premedication before bariatric surgery.

"PD Warrior" is a relatively new exercise program for people with Parkinson's Disease that is widely-used but little studied. Improvements in PD symptoms and beneficial effects on disease progression have been reported in patient surveys. Studies are yet to be undertaken confirming this. HPH-Ramsay Health Plus has a two year experience with PD Warrior and have noticed similar results. This study will assess a group of patients before and after a PD Warrior program using a number of patient outcome measures. The primary outcome will be PD-specific quality of life. Measures of motor outcome will be obtained using the Parkinson's Kinetigraph (PKG), an innovative mobile health technology device developed in Australia. This wrist-worn device is able to measure improvements in tremor, slowness of movement and mobility. We anticipate that the program will provide measurable benefits on quality of life and motor function in our patients. Study Intervention: The PD Warrior 10 week challenge exercise program. Involves attendance at a weekly one hour circuit class and a daily home exercise program. Study Outcomes: Baseline assessments prior to commencing the 10 week challenge exercise program and post completion of the program. These include quality of life (PDQ39 questionnaire), motor outcomes from the MDS- UPDRS scale Part 3 Motor examination, routinely used motor function measures - 10m walk test, 6 minute walk test, Timed Up and Go test, MiniBESTest balance test and timed hand function tests and wearing a Parkinsons Kinetigraph for 7 days pre and post the 10 week challenge exercise program.

This study aims to assess the safety and tolerability of two new drugs in patients with extensive stage small cell lung cancer (ES SCLC). The first drug (68Ga-SSO120/68Ga-Satoreotide Trizoxetan) is used as a tumour imaging agent for patients who have tumours with specific receptors, while the second drug (177Lu-SSO110) targets and damages cancer cells with these specific receptors. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have been diagnosed with extensive stage small cell lung cancer and if you are going to be receiving ICI maintenance therapy. All potential participants will be reviewed by the study investigators to ensure that they meet additional health criteria before enrolment. Study details All participants who choose to enrol in this study will undergo two screening scans using the new 68Ga-SSO120 imaging drug. The first scan will be to confirm eligibility to receive the 177Lu-SSO110 drug. If eligible, the first treatment dose with 177Lu-SSO110 will be scheduled at least 18 days after the 68Ga-SSO120 scan. The second scan with 68Ga-SSO120 will be taken at the end of treatment visit, which will be 6 weeks following the last dose of 177Lu-SSO110. For each scan, the 68Ga-SSO120 drug will be administered via an intravenous infusion 1 hour (40-90 minutes) before the PET/CT scan. The scans are anticipated to take 1-2 hours in total to complete. Participants who are confirmed to have somatostatin receptor 2 tumour cells based on the first screening scan will then be offered the opportunity to undergo treatment with the 177Lu-SSO110 drug. Participants who choose to enrol in the 177Lu-SSO110 arm of this study will have 177Lu-SSO110 administered via an intravenous infusion within 7 weeks after their last induction ICI therapy. Up to 3 additional 177Lu-SSO110 administration cycles will be given 6 to 9 weeks after the previous 177Lu-SSO110 administration. For participants with clinical benefit at the end of the 4 cycles the Investigator may request that the patient is provided with up to three additional treatments, which will be approved at the Sponsor’s discretion It is hoped this research will demonstrate that each of the study drugs, 68Ga-SSO120 and 177Lu-SSO110 are safe and well tolerated by patients with extensive stage small cell lung cancer. If the results of this initial study are positive, a larger trial involving a greater number of patients with extensive stage small cell lung cancer may be undertaken to further determine the potential benefits of the new drugs.

Athletes across many disciplines engage in structured, periodized training plans to promote adaptation and ultimately optimise performance. However, recent research has made it clear that manipulating the provision of nutritional support throughout training and during the recovery periods can play an equally important a role in determining performance outcomes. Over the last 20+ years, exercise science research has primarily focused on the provision of carbohydrate and protein to facilitate glycogen replenishment and skeletal muscle repair, respectively. More recently, scientific studies have begun exploring whether supplementing with beverages containing ketone esters may provide an alternative fuel source to support exercise and subsequent recovery. To date, the evidence to support ketone use during exercise is mixed, but there have been promising findings suggesting that this fuel may promote muscle repair, and may reduce the likelihood of athletes developing symptoms of overtraining. While the finding that exogenous ketones may increase the activity of the machinery response for building new proteins is exciting; it remains to be determined whether supplementing with ketones can increase the rate of muscle protein synthesis (MPS) following exercise. Therefore, the primary aim of this study is to measure the effects of a ketone supplement or energy-matched placebo on MPS following an acute bout of endurance exercise in trained cyclists. In addition to a proposed enhancement of muscle repair and adaptation, the intake of ketone esters is claimed to act as an appetite suppressant to assist with the aggressive manipulation of physique prized by many road cyclists. Indeed, despite reports of an increased energy intake and reduction in markers of over-reaching in a ketone-supplemented group following intensified cycling training, there have been observations of suppression of hormones linked to hunger (e.g., ghrelin), self-reported hunger and desire to eat in the hours following the intake of ketone ester supplements in sedentary humans and supportive evidence in rodent models. Other effects associated with post-exercise ketosis achieved via adaptation to a ketogenic diet also merit investigation in relation to the post-exercise supplementation with ketone esters; these include alterations to iron and bone metabolism. Therefore, the secondary aim of this study is to examine the effect of ketone ester supplementation on other effects on post-exercise recover including impacts on hunger and appetite, as well as on markers linked to iron metabolism and bone health.

The majority of patients undergoing oesophageal/stomach cancer surgery have reduced fitness. This means they are at greater risk for, and struggle to overcome post-surgical complications, which leads to further morbidity and mortality. This study aims to assess whether a prehabilitation exercise and nutrition program administered to participants prior to surgery has any impact on their physical, nutritional and psychological wellbeing after surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with gastric, gastroesophageal junction or oesophageal cancer, you are scheduled to receive or are currently undergoing chemotherapy, radiotherapy or both and you are going to undergo elective surgery to treat your cancer after completing these therapies. Study details All participants who choose to enrol in this study will be given a personalised diet and exercise program to follow for 3 months prior to their elective surgery. During the initial visit, participants will undergo a series of physical assessments to determine their current fitness levels and will be asked to provide a diet history to assess their nutrition status. It is anticipated that this initial assessment will take 60 minutes. After the initial assessment, participants will be given a personalised exercise plan to follow, this will include 2x 45-60 minute one-on-one sessions with a physiotherapist each week for 3 months. Participants will also be asked to undertake additional moderate exercise, e.g. walking, for at least one hour per week for the 3 months. Participants will also be given nutritional advice including suggested meal plans to address target areas (e.g. reducing carbohydrates or increasing protein or vitamin intakes) to follow over the 3 months prior to their surgery. For the 5 days prior to and 5 days after their surgery, participants will also be provided with an immune-modulating supplement (drink) to consume. Participants who are assessed as at risk for anxiety and depression, and those participants who are struggling to comply with their exercise plan will also be offered one-on-one psychological counselling. Data collected from participants who are undergoing these interventions will be compared to historical patients who received standard of care prior to their surgery. It is hoped this research will demonstrate whether a targeted prehabilitation program has a positive effect on the physical, nutritional and mental wellbeing of patients who are undergoing treatment for gastric and oesophageal cancers. If this study does show a positive effect, the prehabilitation program may be expanded to a greater number of cancer patients.