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Active Not RecruitingNCT03939481

Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer

A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane-Induced Peripheral Neuropathy in Cancer Patients

Status
Active Not Recruiting
Phase
—
Study type
Observational
Enrollment
1,336 (actual)
Sponsor
SWOG Cancer Research Network · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: 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 OBJECTIVES: I. To collect serum and plasma samples for future testing for biomarker and mechanistic studies of CIPN. OUTLINE: Patients receive chemotherapy regimen per treating physician for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete questionnaires at weeks 4, 8, 12, 24 and 52.

Conditions

Interventions

TypeNameDescription
DRUGChemotherapyGiven chemotherapy regimen
OTHERFunctional AssessmentFunctional and sensory clinician assessments
OTHERQuestionnaire AdministrationPatient and physician reported responses

Timeline

Start date
2019-05-14
Primary completion
2025-04-08
Completion
2026-09-01
First posted
2019-05-06
Last updated
2026-04-13

Locations

169 sites across 4 countries: United States, Chile, Colombia, Mexico

Source: ClinicalTrials.gov record NCT03939481. Inclusion in this directory is not an endorsement.

Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer (NCT03939481) · Clinical Trials Directory