Investigating the Temporal Relationship: Chemotherapy-Induced Peripheral Neuropathy in Children and Adolescents with Cancer
Investigating Chemotherapy-Induced Peripheral Neuropathy in Young Cancer Patients
Jenny Belsky, DO
Primary Investigator
Brief description of study
Cancer treatment can sometimes lead to the development of a condition called peripheral neuropathy. This is when your arms, hands, legs, and feet may tingle, like they are asleep, or cause pain. We want to look at characteristics that might predict who will develop this condition. Only eligible patients that have been referred by a physician or self-referred to and seen by section of Pediatric Hematology/Oncology staff will be invited to participate in the clinical trial. Potential subjects will be contacted in the hospital or at a clinic visit in Pediatric Hematology/Oncology.
Detailed description of study
Study participation involves a baseline blood sample, day 1 of each new chemotherapy cycle, end of therapy, and then every 3 months post-therapy until no neuropathy symptoms.
• History and physical examination
• Blood draw through your already existing port of about 2 teaspoons of blood, no additional port accesses are needed. Labs will be drawn with routine medical labs.
• A trained research nurse will do a 5-minute focused, physical exam to see how the nerves are working.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Chemotherapy-Induced Peripheral Neuropathy, Cancer, Riley
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Age: 2 years - 20 years
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Gender: All
Inclusion Criteria
1. ≥ 2 to 2. Ability to provide written informed consent/assent and HIPAA authorization
3. An oncology diagnosis of any malignancy requiring neurotoxic chemotherapy
4. Plan to receive the entirety of their care at Riley Hospital for Children
Exclusion Criteria
• Patients with relapsed or secondary cancers will be excluded from the study due to confounding baseline variables
• Patients with pre-existing neurologic conditions, mass compressing the median motor, median sensory, peroneal motor, or sural nerves will be excluded due to confounding baseline variables
This study investigates chemotherapy-induced peripheral neuropathy in children and adolescents with cancer. Peripheral neuropathy is a condition where nerves outside the brain and spinal cord are damaged, often causing weakness, numbness, and pain, usually in the hands and feet. The purpose of this study is to describe the relationship between a protein called NfL and neuropathy symptoms in young patients with leukemia.
The study uses existing serum samples and neuropathy scores from previous research to examine this relationship. Participants will not receive any new treatments as part of this study, and no changes to their current treatment plan will be made.
- Who can participate: The study is enrolling by invitation only. Participants are children and adolescents with leukemia, identified during routine clinic visits.
- Study details: Participants will provide previously collected serum samples and neuropathy scores for analysis. No new treatments or changes to existing treatments are involved in this study.
