The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on neurotoxicities of cancer treatment. These studies focus on the effects of chemotherapy on cognitive function, changes in resting state brain networks after stem cell transplant, radiation therapy in pediatric oncology patients, markers of peripheral neuropathy, and more. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
OBSERVATIONAL
Study Title: Longitudinal Pilot Mechanistic Study of the Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients and Non-Cancer Control Participants
Study Type: Observational/case-control
Study Sponsor and Collaborators: University of Rochester
Purpose: To understand the prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared with the general population as well as what biologic mechanisms may play a role in the development of these difficulties
Primary Outcome Measures: Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers [time frame: during chemotherapy and 1 month after chemotherapy; approximately 3–5 months]
Principal Investigator: Michelle C. Janelsins, PhD, MPH, University of Rochester; contact Sara Alberti, (585) 273-3998, sara_alberti@urmc.rochester.edu
ClinicalTrials.gov Identifier: NCT03137095
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Study Title: Changes in Resting State Functional Connectivity in Patients With Central Nervous System Lymphoma Receiving High-Dose Chemotherapy and Autologous Stem Cell Transplant
Study Type: Observational/prospective
Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center
Purpose: To test resting state functional magnetic resonance imaging (MRI) scans to see whether they are better the standard task–based functional MRI scans at diagnosing or monitoring central nervous system lymphoma
Primary Outcome Measures: Change in resting state brain networks over time in participants with central nervous system lymphoma before and after treatment with high-dose chemotherapy with autologous stem cell transplantation through resting state functional MRI results [time frame: 6 months]
Principal Investigator: Behroze Vaccha, MD, PhD, Memorial Sloan Kettering Cancer Center; (212) 639-2706, vacchab@mskcc.org
ClinicalTrials.gov Identifier: NCT03342586
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Study Title: An Exploratory Study of Biologic and Pathophysiologic Effects of Radiation Therapy in Pediatric Patients With Central Nervous System Tumors
Study Type: Observational/prospective
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To analyze the effects of radiation given to children who have tumors of the central nervous system (CNS)
Primary Outcome Measures: Changes in angiogenesis, blood brain barrier permeability, and neurotoxicity in response to radiation of the CNS [time frame: before and up to 8 years after]
Principal Investigator: Katherine E. Warren, MD, National Cancer Institute; (240) 760-6202, warren@mail.nih.gov
ClinicalTrials.gov Identifier: NCT01445288
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Study Title: Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer
Study Type: Observational/case-only
Study Sponsor and Collaborators: Children’s Oncology Group (COG), National Cancer Institute
Purpose: To study neuropsychological (learning, remembering, or thinking) and behavioral testing in younger patients with cancer and in turn to develop effective tests to measure neuropsychological and behavioral function of patients with cancer
Primary Outcome Measures: Consistent, streamlined, and efficient administration of neuropsychological and behavioral tests; utilization of standardized battery of age-appropriate neuropsychological and behavioral tests in conjunction with COG phase III clinical trials; percentage of patients who completed the assessment [time frame: up to 60 months]
Principal Investigator: Leanne Embry, Children’s Oncology Group; visit clinicaltrials.gov to see all available study locations
ClinicalTrials.gov Identifier: NCT00772200
INTERVENTIONAL
Study Title: Biomarkers in Chemotherapy-Induced Peripheral Neurotoxicity: Better Tools and Understanding
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Dartmouth-Hitchcock Medical Center
Purpose: To establish the feasibility of using tissue oxygen measurements as a potential biomarker for chemotherapy-induced peripheral neuropathy
Primary Outcome Measures: Change in tissue oxygenation [time frame: three 10-minute readings at the start of chemotherapy, the midpoint of chemotherapy/onset of chemotherapy-induced peripheral neuropathy symptoms, after completion of chemotherapy, over 1 year]
Principal Investigator: Victoria H. Lawson, MD, Dartmouth-Hitchcock Medical Center; contact Kendra A. Hebert, (603) 650-5214, kendra.a.hebert@hitchcock.org
ClinicalTrials.gov Identifier: NCT03348956.
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov. ■
