Investigating the Temporal Relationship: Chemotherapy-Induced Peripheral Neuropathy in Children and Adolescents with Cancer

JB

Jenny Belsky, DO

Principal Investigator

Status: Enrolling By Invitation Ages: 2 Years - 20 Years Gender: All Genders Phase: N/A 1 Locations

Brief Description

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed Description

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

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

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.