View clinical trials related to Pediatric Cancer.
Filter by:To date, most caregiver focused interventions have been targeted at caregivers of adults with cancer, completely ignoring the unique needs of caregivers of children with cancer. A recent meta-analysis indicated that although these interventions had small to medium effects, they significantly reduced burden, improved ability to cope, increased self-efficacy, and improved aspects of caregivers' quality of life. Yet, several recent reviews highlighted a lack of interventions to provide practical skills for the day-to-day provision of care. The investigators have developed a pediatric oncology caregiver-focused intervention that seeks to improve caregiver clinical skills/knowledge, self-efficacy, and support seeking skills. Cope 360 is a mHealth (mobile health) app designed to support caregivers of children with cancer with symptom tracking, medication management, and emergency preparedness. The investigators propose to evaluate Cope 360 via a pilot, randomized control trial in which some caregivers will receive the app and some will not. The purpose of this study is to assess: 1) feasibility of caregiver use over extended period of time, 2) acceptability of the mHealth tool by caregivers in a real-world setting, 3) impact of the mHealth tool on caregiver self-efficacy, mastery of caregiving skills/knowledge, and caregiver stress, and 4) effect on healthcare utilization of the child with cancer (i.e. preliminary data about sick visits and ED encounters).
Physical activity can enhance well-being among youth diagnosed with oncological or hematological diseases. We developed a tailored, 1:1, online physical activity program (i.e., IMPACT), to promote physical activity in this cohort. The proposed single-group, mixed-methods project will assess the effect of IMPACT and explore markers of implementation.
Pain is a vital sign that depends on personal experience involving different factors such as previous sensory and emotional experience, age, spiritual and cultural aspects, that makes it harder to evaluate, especially in young children. Pain control is important to diminish the anxiety of the child and family, also this is more important in patients who require procedure and treatment that are more painful, like oncological and hematological patients. The study aims to measure if the intranasal drugs (dexmedetomidine and fentanyl) has the same outcomes when compared with intravenous drug (ketamine and midazolam), but with less side effects. The participants are patients from an oncologic outpatient, that will be submitted to cerebrospinal fluid puncture, myelogram or both will be randomized assigned to both groups. The study will compare physiological variables ( heart rate, respiratory rate and blood pressure) and sedation and pain scales to see if its work properly. The study purpose is to evaluate if intranasal drug works in the same way with less side effects comparing with the usual treatment.
The aim of this study is to evaluate the feasibility of an randomised-controlled trial to investigate the efficacy of liquid probiotics to prevent or reduce mucositis and infection in children diagnosed with cancer who are undergoing treatment with regimes likely to cause mucositis.
Sugammadex is a selective antidote to muscle relaxants rocuronium bromide and vecuronium bromide. Sugammadex is a modified gamma-cyclodextrin, a compound that selectively binds rocuronium bromide and vecuronium bromide. It forms a complex with them in the blood plasma, which leads to the decrease in the concentration of muscle relaxant binding to nicotinic receptors in the neuromuscular synapse. The result is the the elimination of neuromuscular blockade caused by rocuronium bromide or vecuronium bromide. Sugammadex is used to eliminate neuromuscular blockade caused by rocuronium bromide in children aged 2 years and adolescents in standard clinical situations. The aim of the study is to prove the efficacy and safety of sugammadex in children under 2 years
Adapted physical activity (APA) in the context of cancer is a field of growing interest and has been explored in numerous publications. In adults, the effects of APA on survival, symptoms and quality of life are established and its physiological consequences on immunity, angiogenesis and hormone secretion are under investigation. In children and adolescents, evidence is scarce: pilot studies show clinical benefit of physical activity practiced in a wide variety of situations and protocols with low level of scientific evidence. It is therefore not possible to recommend this practice in pediatrics despite the large number of initiatives and the conviction of many clinicians that there is a benefit for patients. In particular, there are few trials in children with advanced cancer pathologies or in palliative care. However, these patients have a high prevalence of severe symptoms (pain, digestive disorders, asthenia, and anxiety) for which physical activity may represent a therapeutic option. The purpose of our study is to describe a protocol of adapted physical activity and to evaluate its feasibility and toxicity according to a well-known and validated methodology in oncology used in drug development. Methodology is based on a simple and reproducible intervention combining brisk walking on treadmill and exercises of muscular strengthening with varying durations and intensities depending on physical capabilities of patients. The primary objective is to define the volume of physical activity that can be proposed to a patient starting APA based on the assessment of his physical condition evaluated by a 6-minutes walking distance test. Inclusion criteria are broad to allow study population to represent the diversity of patients in pediatric palliative oncology. Stratification of patients in three groups based on a 6-minutes walking distance test aims to adapt intervention to physical capability of patients and improve tolerance. Dose escalation will be set with a "3 + 3" regimen used in drug early phases trials. Primary outcome measure is perceived tolerance evaluated by the patient with a subjective scoring on CREST scale. Any score greater than 8/10 defines intolerance.
Cancer remains the first cause of death due to disease in children and adolescents despite important progress and 70% of the survivors present sequelae. It is therefore mandatory to generate new and preferably less toxic treatment strategies relying on new anticancer agents, and/or new combinations or schedules of administered compounds. Metronomic chemotherapy (MC) consists in administrating low doses of anticancer agents on a daily/weekly basis. MC has been showed to be a safe and effective way to administer chemotherapy to obtain anti-cancer effects through anti-angiogenic and pro-imune effects. Drug repositioning consist in using non-anticancer drug for which anti-cancer properties have been unveiled. Propranolol is a non selective beta-blocker initially used to treat hypertension but recently its anticancer properties have been discovered. The place of Betablockers as anticancer agents is supported by both preclinical and epidemiologic data. The investigators have showed that the use of betablockers could sensitize breast cancer, angiosarcoma and neuroblastoma to chemotherapy in vitro and in vivo at least in part via an anti-angiogenic mechanism. There are currently 12 clinical trials evaluating prospectively their potential in adults with cancer but none in children so far. The Objective is to determine the Maximal Tolerated Dose (MTD) of a combination of oral metronomic vinorelbine and daily oral propranolol. This study is a phase I trial with a "rolling six" design and a dose escalation with thrice weekly oral vinorelbine only plus addition of daily oral propranolol after completion of the first cycle. PK analysis of vinorelbine and propranolol will be performed. Once the recommended dose of the combination established 4 extension cohorts of 9 patients will be added Potential biomarkers (such as beta-adrenergic receptors on the tumours, B-tubulin isotypes in the tumour) will also be evaluated. This will provide a well tolerated, all oral combination for patients with refractory/relapsing tumours. This combination could also be then proposed as a maintenance for instance in patients with rhabdomyosarcoma or neuroblastoma.