Active clinical trials for "Brain Neoplasms"

This study evaluates the feasibility and utility of two behavioural programs designed to reduce cognitive impairments secondary to brain tumors and/or their treatment. One-third of participants will complete training in either program, with the remaining third a wait-list control group.

RATIONALE: Armodafinil may help relieve fatigue and improve quality of life in patients with cancer receiving radiation therapy to the brain. PURPOSE: This clinical trial is studying how well armodafinil works in treating fatigue caused by radiation therapy in patients with primary brain tumors.

RATIONALE: Zoledronate may prevent bone loss in patients with primary malignant glioma. PURPOSE: This phase II trial is studying how well zoledronate works in preventing osteoporosis in patients with primary malignant glioma.

RATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of life in patients who have undergone radiation therapy for brain tumors. It is not yet known whether donepezil is more effective than a placebo in lessening side effects of radiation therapy in patients with brain tumors. PURPOSE: This randomized phase III trial is studying donepezil to see how well it works in lessening side effects of radiation therapy compared with a placebo in patients who have undergone radiation therapy for brain tumors.

With a trend for increased survival in patients with Brain and Central Nervous System (CNS) cancers, emphasis is increasingly shifting to improving the quality of life of survivors. Performance status (a quantification tool used in patients with cancer to assess their quality of life and ability to carry out activities of daily living) is a key prognostic factor in Brain and CNS cancers and a good performance status is used in determining whether a patient is offered adjuvant treatment with chemotherapy and radiotherapy following primary surgical treatment. The performance status of a patient is defined by physical and cognitive functioning, and the beneficial effect of aerobic exercise in improving physical functioning (e.g., cardiorespiratory fitness) is well established. Thus, it is anticipated that implementing a supervised moderate intensity aerobic exercise training programme will improve the performance status of patients. An implication of this work is that, exercise regimens could be offered as additional treatment, alongside chemotherapy and radiotherapy, which might increase the chance of survival. The project design is a randomised controlled trial with two arms in which one group of patients will undergo an aerobic exercise program starting one week before surgery and continuing for three weeks in the post-operative period. Patients enrolled in this trial will continue with standard treatment including neuro-rehabilitation. The control group of patients will be given written instructions on performing flexibility and stretching exercises in addition to their usual care (including neuro-rehabilitation). The primary outcome is performance status as defined by measurements of physical functioning and cognitive ability (e.g., memory, attention, information processing speed). Physical functioning will be assessed by a timed walking test, hand-grip dynamometry and a maximum jump height test. Other measures of well-being will be assessed; including heath related quality of life using the European Quality of Life-5 Dimensions (EQ-5D) and Functional Assessment of Cancer Therapy- Brain (FACT-Br) questionnaires. Secondary outcome measures will be measurements of mood, fatigue and certain biochemical parameters, such as C-reactive protein (CRP), plasma viscosity (PV), full blood count (FBC), uric acid, insulin-like growth factor 1 (IGF-1), and insulin-like growth factor binding protein 3 (IGFBP-3). It is anticipated that a total of 30 patients will be recruited split between the two groups and each participant will not spend more than four weeks in taking part in the study.

Hematopoietic cell transplantation (BMT), or commonly referred to as blood and marrow transplantation (BMT), is a potentially life-saving therapy for many malignant and non-malignant conditions. Despite advances over the past decade, which have led to improved outcomes, BMT remains an intense treatment modality often requiring prolonged inpatient-based care. While many patients endure the acute complications of the procedure, it is common for BMT patients and their caregivers to experience increased risk of financial and emotional burden, hospital readmission, and health service utilization. This highlights the importance of active involvement of BMT patients in their own health care (self-efficacy). For pediatric BMT patients, parents are the primary caregivers. As such, parental activation on behalf of the child (patient) plays a critical role in effective patient-parent-provider partnerships, which is increasingly recognized as the optimal model for health care delivery, particularly for those facing life-altering medical treatments. It is essential to develop effective strategies to enhance this partnership. Health information technology (IT)-mediated tools offer the potential to overcome constraints in health care delivery limited by provider time, complicated health information, and financial pressures. Significant gaps in knowledge exist on the use of health IT tools using low-cost and well-accepted delivery platforms in routine inpatient care, especially for high-risk or critically ill populations. The investigators hypothesize that a tablet-based tool displaying personal health information could provide a platform to promote caregiver (parent) activation and enhance health communication. In this clinical research study, the investigators will conduct a pilot study of an educational health IT system developed on a tablet (Apple iPad®) that the investigators refer to as a Personalized Engagement Tool (PET) or the "BMT Roadmap." The Apple iPad® was selected as the platform for delivery of the educational intervention given its ergonomic features. The implementation and evaluation of the BMT Roadmap information system in caregivers of children undergoing BMT have been based on the generation of user (caregivers and patients) needs that incorporated well-established user-centered design processes including qualitative and quantitative research methods (published and unpublished data). The assembled investigators represent a strong multidisciplinary team with complementary and integrated expertise who are well-poised to carry out the proposed research. The Protocol or Study Team includes pediatric BMT physicians, Center for Health Communications Research (CHCR) staff, health informaticist, biostatistician, and psychologist. This research study is innovative because it addresses a gap in the literature on the role of health IT in parent activation on behalf of the child in the inpatient setting of a high-risk BMT population. The BMT Roadmap information system provides a robust experimental framework for further testing the utility of other care components that relate to parent activation or participation and for potential adoption in other complex medical conditions. The new knowledge gained herein will thus contribute to the evidence base of how health IT improves health care quality and provide the basis of further study in a full-scale clinical trial.

the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years. This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients.

This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site (place where it started) to the brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately, the majority of patients with brain metastases experience cognitive (such as learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal region during WBRT, may reduce the radiation dose to the hippocampus and help limit the radiation-induced cognitive decline. It is not yet known whether giving memantine hydrochloride and WBRT with or without hippocampal avoidance works better in reducing neurocognitive decline in patients with brain metastases.

Children with brain tumors who have had radiation therapy are at risk for problems with attention, memory, and problem solving. Such problems may cause difficulty in school and daily life. Memantine, the drug being used for this study, is not yet approved for use in children by the U.S. Food and Drug Administration. However, studies have shown some improvements in memory for patients with dementia, Attention Deficit Hyperactivity Disorder, and autism. Scientists have also used this medication for adult cancer patients receiving radiation therapy with results showing less cognitive declines over time compared to patients taking a placebo (inactive pill). These studies have also shown few side effects. This is a pilot/feasibility study and the first known study involving children with a cancer diagnosis or brain tumor. PRIMARY OBJECTIVES: To estimate the participation rate in a study of memantine used as a neuro-protective agent in children undergoing radiotherapy for localized brain tumors (low grade glioma, craniopharyngioma, ependymoma, or germ cell tumor) To estimate the rate of memantine medication adherence To estimate the rate of completion of cognitive assessments SECONDARY OBJECTIVES: To estimate the effect size of change in neurobehavioral outcomes (cognitive, social, quality of life, neurologic) associated with memantine To evaluate the frequency and nature of memantine side effects as measured by the Systematic Assessment for Treatment Emergent Events (SAFTEE)

The integrated cancer research site (SIRIC) of Montpellier proposes to develop a prospective and regional Clinical Database Project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient's management with brain metastases including quality of life and neuropsychological/cognitive aspects.