This trial studies treatment effects on development of chemotherapy-induced peripheral neuropathy in patients with cancer. Treatments for cancer can cause a problem to the nervous system (called peripheral neuropathy) that can lead to tingling or less feeling in hands and feet. Studying certain risk factors, such as age, gender, pre-existing conditions, and the type of treatment for cancer may help doctors estimate how likely patients are to develop the nerve disorder.
Additional locations may be listed on ClinicalTrials.gov for NCT03939481.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To develop and validate a clinical risk prediction model using clinical factors for the development of peripheral neuropathy in patients receiving taxane-based chemotherapy regimens.
SECONDARY OBJECTIVES:
I. To examine patient-reported outcomes (PROs) and objective measures of chemotherapy induced peripheral neuropathy (CIPN) to better define the phenotype of peripheral neuropathy in this patient population.
II. To assess the incidence of CIPN within one year in this patient population.
III. To identify predictors of treatment dose reductions, delays, and discontinuations associated with CIPN symptoms in this patient population.
OTHER OBJECTIVE:
I. To collect serum and plasma samples for future testing for biomarker and mechanistic studies of CIPN.
IMAGING OBJECTIVE:
I. To estimate skeletal muscle area (SMA)-based taxane infusion rates for 1-hour paclitaxel (Pac1h) and docetaxel (Doc1h) to prevent supratherapeutic maximum concentration (Cmax) and reduce taxane-induced peripheral neuropathy (TIPN) risk in female patients with breast cancer.
OUTLINE:
Patients receive chemotherapy regimen per treating physician for 156 weeks (3 years) in the absence of disease progression or unacceptable toxicity. Patients also complete questionnaires and undergo blood sample collection at baseline and while on study. Patients may also optionally have their standard computed tomography (CT) scan image data collected on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationSWOG
Principal InvestigatorMeghna S. Trivedi
