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60 active trials for Pediatric Cancer

9-ING-41 in Pediatric Patients With Refractory Malignancies.

9-ING-41 has anti-cancer clinical activity with no significant toxicity in adult patients. This Phase 1 study will study its efficacy in paediatric patients with advanced malignancies.

Start: June 2020

Dual Task Gait Performance in Pediatric Oncology Patients

Cancer incidence, which is recognized as the leading cause of death in children worldwide, is gradually increasing. Most studies on children who survive cancer show that the disease and its treatment have side effects and long-term late effects on the musculoskeletal system, physical function, gait and cognitive skills. Therefore, dual task gait performance, in which cognitive and motor tasks are performed simultaneously, may be affected in pediatric oncology patients. The aim of this study is to compare gait performance in single and dual task conditions in pediatric oncology patients with healthy controls.

Start: March 2021

TEMOkids Study : A Phase I Pediatric Study for KIMOZO, Oral Suspension of Temozolomide

Non-randomized, international, multi-centre, open-label, single arm study to determine the pharmacokinetic (PK) parameters of a single dose of an oral suspension of temozolomide (KIMOZO) in the pediatric population aged 1 year and over.

Start: March 2021

Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer

The INTERACT study is a nation-wide, population-based randomized controlled trial to investigate the effects of 6-month integrative neuromuscular training during anti-cancer treatment on lower body muscle strength, metabolic syndrome, various measures of physical function, physical activity, days of hospitalization, health-related quality of life and health behavior in children and adolescents with cancer. The increased insight derived from this study will impact the development of pediatric exercise oncology and be of high relevance to a broad group of children and adolescents with severe chronic illness. The study is based on the overarching hypothesis, that structured integrative neuromuscular training initiated immediately after diagnosis will be effective in preventing deficits in neuromuscular function, limit long-term cardio-metabolic morbidity and found long-standing improvements in physical activity behavior. To maintain adherence and motivation throughout a 6-month training intervention, weekly supervision of the training is needed. For this study, it is hypothesized that a supervised exercise intervention, in addition to a motivational counseling intervention and usual care, will improve muscle strength compared with unsupervised home-based training (active controls).

Start: January 2021

Durvalumab and Tremelimumab for Pediatric Malignancies

The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and expand in a second phase to test the efficacy of these drugs once this dose is determined.

Start: March 2019

A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors

This study is looking to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of lyso-thermosensitive liposomal doxorubicin (LTLD) administered in combination with MR-HIFU in children with relapsed/refractory solid tumors, which may include but are not limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, and germ cell tumors.

Start: October 2016

Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images

This research study establishes a repository for imaging data generated during image-guided proton therapy for various pediatric cancers. The data facilitate the estimation of patient positioning uncertainty, the comparison of image guidance methods, and the identification of factors contributing to large setup deviations to improve the accuracy of radiation therapy in the future. Primary Objective To establish a repository of imaging data acquired during the radiation therapy course with linked radiation treatment plans and clinical information from pediatric patients of all cancer types receiving image-guided proton therapy to facilitate secondary and exploratory objectives. Secondary Objectives To estimate distributions of patient setup uncertainty measured with daily pre- treatment volumetric cone beam computed tomography (CBCT) scans. To compare patient setup corrections derived based on 2D (orthogonal radiographs) and 3D (volumetric CBCT scans) image guidance. To assess residual setup errors after CBCT-guided correction based on post- correction repeat CBCT. To estimate distributions and time trends of patient motion during a radiation therapy course based on weekly pre- and post-treatment CBCT scans. To identify clinical and treatment factors that contribute to significantly large setup uncertainty and intra-fractional movement in pediatric patients. Exploratory Objectives To determine variation in patient anatomy using images acquired during the treatment course. To evaluate the usefulness of on-treatment CBCT scans for detecting daily changes in proton ranges, evaluating deviations from planned tumor dosimetry, and triggering adaptive replanning.

Start: January 2020

Communicating With Patients on Cancer Resistance to Treatment: the Development of a Communication Tool. (HECTOR)

Resistance to treatment is one of the major themes in cancer research. Despite this, the definition and clinical implications of resistance to treatment remain under-explored, and patient-physician communication in this context still constitutes a challenge. When resistance to cancer treatments occurs, physicians not only have to explain to the patient the phenomenon of resistance, often based on complex results (biological results, genomic tests, imaging, etc.), but also need to offer alternative therapies, whilst fostering shared medical decision-making. These different tasks are particularly challenging for clinicians, especially since there are large individual differences at patient level. Indeed, each patient has his or her own unique information needs, capacity for understanding, and level of desire to participate in treatment decisions.

Start: February 2021

eHealth as an Aid for Facilitating and Supporting Self-management in Families With Long-term Childhood Illness

The overall aim is twofold: 1) to stretch the borderline regarding the present knowledge of clinical and economic cost-effectiveness of eHealth as an aid for facilitating and supporting self-management in families with long-term childhood illness, and 2) to develop a sustainable multidisciplinary research environment for advancing, evaluating, and implementing models of eHealth to promote self-management for children and their families. A number of clinical studies are planned for, covering different parts of paediatric healthcare. The concept of child-centred care is essential. Experienced researchers from care science, medicine, economics, technology, and social science will collaborate around common issues. Expertise on IT technology will analyse the preconditions for using IT; economic evaluations will be performed alongside clinical studies; and cultural and implementation perspectives will be used to analyse the challenges that arise from the changes in relations among children, family and professionals, which may occur as a result of the introduction of eHealth. Child health is not only important in itself. Investments in child health may also generate significant future gains, such as improved educational and labour market performance. Six complex, long-term and costly challenges in paediatric healthcare are planned for, involving eHealth technology such as interactive video consultation, pictures, on-line monitoring, and textual communication. The research follows an international framework for developing and evaluating complex interventions in healthcare. End-users (families) and relevant care providers (professionals in health and social care) will participate throughout the research process. The overall aim is certainly to analyse eHealth as an aid for facilitating and supporting self-management. However, the plan also includes the research issue whether eHealth at the same time improves the allocation of scarce health care- and societal resources.

Start: October 2019

Beat Childhood Cancer Specimen Banking and Data Registry

This is an observational data registry study of all pediatric cancer patients at Atrium Health (AH) and participating Beat Childhood Cancer Consortium sites involving specimen banking and data collection.

Start: February 2021

Symptom Screening Linked to Care Pathways

Most children with cancer survive because they are given intensive treatments, but unfortunately, these treatments are associated with distressing symptoms. To address this problem, we developed the Symptom Screening in Pediatrics Tool (SSPedi) so that children receiving cancer treatments can communicate their bothersome symptoms, and Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK), a web-based application that links identified symptoms to supportive care guidelines for symptom management. To establish that these tools improve the lives of children newly diagnosed with cancer, we will conduct a trial that randomizes 20 pediatric cancer institutions and measures the impact of three times weekly symptom screening, symptom feedback to healthcare providers and the development of care pathways for symptom management to improve total symptom burden, fatigue and quality of life.

Start: May 2021

Hospital Based Registry of Childhood Cancer in Pediatric Oncology Units in French Speaking Africa

The ultimate aim of this registry is to collect precise information concerning the children coming to oncology units working with the French African Oncology Group. This data will help to plan and provide correct pediatric oncology treatment and care for this population. Collecting the data will give much needed information on numbers, stage, treatment and outcome. The register will give data for local and national health authorities in planning pediatric cancer programs.

Start: January 2016

Longitudinal Identity Study of Childhood Cancer Survivors

The study investigators plan to conduct a longitudinal questionnaire study in adolescents and emerging adults (14-25 years of age at the start of the study) who survived childhood cancer to chart their identity development and broader social functioning. Additionally, the functioning of these survivors will be related to the functioning of their parents and siblings. The investigators shall focus especially on the current experience and impact of the earlier cancer experience. They will investigate to what extent the experience of a life-threatening disease has an effect on the daily life of survivors and over time and how the survivors develop through the course of adolescence and emerging adulthood on the psychosocial level. The formation of an adult identity is a very challenging task during adolescence and the way to adulthood and the fact that these youth had cancer during their childhood may especially complicate this process of identity formation. Furthermore, both parental and sibling functioning will be taken into account, which will allow us to examine inter-generational mechanisms (thus parental functioning that possibly impacts youth functioning and vice versa) and sibling functioning in these families. To investigate the latter, at each timepoint of the longitudinal study a sibling between 14 and 25 years of age at the start of the study will be included (if there is more than one sibling in a family, ideally the sibling who is closest in age will be the one who participates in the study). Moreover, a community sample that is matched on age and sex with the survivor of pediatric cancer will be assessed. This will allow the investigators to make well-founded comparisons regarding identity development and broader psychosocial functioning.

Start: August 2018

A Pilot Randomized Controlled Trial for Feasibility of Administering an AR Game to Postoperative Pediatric Cancer Patients

This is a pilot study to evaluate the feasibility of SpellBound's AR (augmented reality)-enabled scavenger hunt use among 20 pediatric cancer patients undergoing surgery.

Start: January 2021

The Effect of Occupational-Based Nursing Program Applied to Pediatric Oncology Patients

Nurses can include the child in their occupational activities by using the therapeutic communication techniques they have learned during their education. However, there is no occupational-based nursing program that is routinely implemented for children in pediatric clinics. Therefore, the aim of this study is to investigate the effect of occupational-based nursing program on increasing child satisfaction as well as reducing the symptoms of chemotherapy in pediatric oncology patients.

Start: January 2021

Rehabilitation Including Play and Movement Activities for Preschool Children With Cancer.

Treatment for childhood cancer causes treatment-related acute adverse events such as muscle weakness and physical incompetence. With long admissions, isolation, and long-term bed rest, this means reduced physical activity and, ultimately, gross motor functioning development is affected. Furthermore, the children participate less in sport and leisure activities, inhibiting social skills, and the children feel isolated from peers. The above makes it difficult for children to return to everyday activities. Physical activity in the form of play and movement activities is essential for preschool children's gross motor, social, and personal development- a development where parents play a crucial role. Replay is a randomized controlled trial that will include 84 children with cancer aged 1-5 years at the University Hospital Copenhagen, Rigshospitalet. The children are included at the treatment initiation and are randomized to either the intervention group or the control group. The intervention consists of six months of daily structured play-based physical activity, including daily parent administered play and movement and three weekly group-based play and movement sessions at the hospital during admissions. Gross motor and physical function is measured with 1) Peabody Developmental Motor Scales, Second Edition (PDMS-2), Pediatric Evaluation of Disability Inventory (PEDI), Handgrip strength, and a six-minute walk test. The assessment time points are baseline (initiated timepoint), 3- and 6 months (endpoint) after initiated treatment. The intervention group will be observed and invited to participate in qualitative interviews. The control group will receive usual care and specific physiotherapy if needed.

Start: January 2020

The Effect of Using Interactive Mobile Application for the Management of Chemotherapy- Induced Nausea and Vomiting in Children

The aim of this study was to develop an interactive mobile application and to investigate the effect of this application on the management of nausea and vomiting symptoms by using it during chemotherapy treatment.

Start: January 2019

Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients

The aim of this study is to evaluate the analgesic efficacy of erector spinae plane block in pediatric cancer patients undergoing open nephrectomy

Start: November 2020

Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation

Children with cancer undergo many procedures as part of their treatment, and are often hospitalized or have frequent clinic visits, which can be distressing. Using robots or toys may be promising interventions as they provide elements of distraction therapy to children undergoing stressful and painful medical procedures. The purpose of this study is to see whether the use of a robotic toy called My Special Aflac Duck will reduce distress in children who have been diagnosed with cancer. This multi-center study will involve 20 children, ages 3-10, at each of 8 hospitals and their parent or guardian. There will be a total of 160 participants enrolled nationally.

Start: September 2020

Early Termination of Empirical Antibiotics in Febrile Neutropenia in Children With Cancer

The study is a nationwide, multicenter, open label, randomized controlled trial. A target population of 220 children in treatment for cancer with neutropenic fever and a neutrophil count below 0.5 × 10? cells/L with expected duration for more than 7 days will be recruited during the first 48 hours of antibiotic treatment (24 months inclusion period). They will be randomized 1:1 as follows: Experimental group: Discontinuation of antibiotics, despite neutrophil count below 0.5 × 10? cells/L, after 48 hours of apyrexia and clinical stability Control group: Discontinuation of antibiotics when neutrophil count is equal to or above 0.5 × 10? cells/L and the child is afebrile and clinically stable (up to maximum of 14 days after apyrexia and clinical stability). Primary endpoint is the number of days without antibiotic treatment in 28 days after treatment initiation. Secondary endpoints are crude mortality, severe adverse events, days with relapsing fever, and alterations of the microbiome.

Start: November 2020