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

Active:	No
Cancer Type:	Lung Cancer Solid Tumor	NCT ID:	NCT03939481
Trial Phases:	Phase III	Protocol IDs:	S1714 (primary) S1714 SWOG-S1714 NCI-2018-01568
Eligibility:	18 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	SWOG
NCI Full Details:	http://clinicaltrials.gov/show/NCT03939481

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.

Objectives

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.

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.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.