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ACTIVE NOT RECRUITING

NCT03939481

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

Sponsor: SWOG Cancer Research Network

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1336

Start Date

2019-05-14

Completion Date

2026-02-28

Last Updated

2025-09-17

Healthy Volunteers

Conditions

Interventions

DRUG

Chemotherapy

Given chemotherapy regimen

OTHER

Functional Assessment

Functional and sensory clinician assessments

OTHER

Questionnaire Administration

Patient and physician reported responses

Inclusion Criteria: * Patients must have stage I, II, or III primary non-small cell lung, primary breast, or primary ovarian cancer based on clinical or pathologic evaluation. Patients with Stage IV disease are not eligible. * Patients must be planning to start treatment with a taxane-based chemotherapy as part of one of the study-approved taxane regimens (docetaxel chemotherapy regimens for treatment of breast or ovarian cancer, or paclitaxel chemotherapy regimen for treatment of breast, non-small cell lung, or ovarian cancer) within 14 days after registration. (Note that docetaxel or paclitaxel may be administered with a non-neurotoxic chemotherapy, such as cyclophosphamide, and/or biologic agent, such as trastuzumab, and/or carboplatin. Additionally, nab-paclitaxel may not be substituted for paclitaxel for purposes of this study.) * Patients who will receive treatment in the setting of any other clinical trial are eligible as long as it is one of the study-approved regimens. Patients may receive additional treatments (i.e., experimental therapy, immunotherapy, biologics, etc.) as part of another clinical trial in addition to any regimen approved in this study. * Patients must not have received a taxane (paclitaxel, docetaxel, or protein-bound paclitaxel), platinum (cisplatin, carboplatin, or oxaliplatin), vinca alkaloid (vinblastine, vincristine, or vinorelbine), or bortezomib-based chemotherapy regimen prior to registration. (Note that while patients must not have received carboplatin in the past, patients may receive a carboplatin-containing regimen after registration as part of the docetaxel or paclitaxel regimen.) * Patients who can complete Patient-Reported Outcome (PRO) instruments in English or Spanish must: * Agree to complete PROs at all scheduled assessments * Complete the baseline PRO forms prior to registration * Patients with pre-existing neuropathy are eligible, including those with diabetes and neurological conditions such as multiple sclerosis or Parkinson?s disease. * Patients must agree to submit required specimens for defined translational medicine. * Patients must be offered the opportunity to submit additional optional specimens for future, unspecified translational medicine and banking. With patient?s consent, specimens must be submitted. * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. * As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

Locations (169)

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Desert Regional Medical Center

Palm Springs, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Bayhealth Hospital Kent Campus

Dover, Delaware, United States

Bayhealth Hospital Sussex Campus

Milford, Delaware, United States

Florida Gynecologic Oncology

Fort Myers, Florida, United States

Regional Cancer Center-Lee Memorial Health System

Fort Myers, Florida, United States

Sacred Heart Hospital

Pensacola, Florida, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Straub Clinic and Hospital

Honolulu, Hawaii, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, United States

Hawaii Cancer Care - Savio

‘Aiea, Hawaii, United States

Pali Momi Medical Center

‘Aiea, Hawaii, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

Carle on Vermilion

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Little Company of Mary Hospital

Evergreen Park, Illinois, United States

Edward Hines Jr VA Hospital

Hines, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Trinity Medical Center

Moline, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

The Carle Foundation Hospital

Urbana, Illinois, United States

McFarland Clinic PC - Ames

Ames, Iowa, United States

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, United States

Mercy Hospital

Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Greater Regional Medical Center

Creston, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Broadlawns Medical Center

Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Laurel

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

HaysMed University of Kansas Health System

Hays, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Olathe Health Cancer Center

Olathe, Kansas, United States

Salina Regional Health Center

Salina, Kansas, United States

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, United States

Associates In Womens Health

Wichita, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Flaget Memorial Hospital

Bardstown, Kentucky, United States

Saint Joseph Hospital East

Lexington, Kentucky, United States

Saint Joseph London

London, Kentucky, United States

Louisiana State University Health Science Center

New Orleans, Louisiana, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, United States

Harold Alfond Center for Cancer Care

Augusta, Maine, United States

Waldo County General Hospital

Belfast, Maine, United States

MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford

Biddeford, Maine, United States

Penobscot Bay Medical Center

Rockport, Maine, United States

MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford

Sanford, Maine, United States

Maine Medical Center- Scarborough Campus

Scarborough, Maine, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

University of Maryland Shore Medical Center at Easton

Easton, Maryland, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Winchester Hospital

Winchester, Massachusetts, United States

Mercy Health Saint Mary's

Grand Rapids, Michigan, United States

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

Spectrum Health Reed City Hospital

Reed City, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

Metro Health Hospital

Wyoming, Michigan, United States

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Monticello Cancer Center

Monticello, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Essentia Health Sandstone

Sandstone, Minnesota, United States

Lakeview Hospital

Stillwater, Minnesota, United States

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

CHI Health Saint Francis

Grand Island, Nebraska, United States

Saint Joseph Hospital

Nashua, New Hampshire, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Randolph Hospital

Asheboro, North Carolina, United States

AdventHealth Infusion Center Asheville

Asheville, North Carolina, United States

Cone Health Cancer Center at Alamance Regional

Burlington, North Carolina, United States

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, United States

AdventHealth Infusion Center Haywood

Clyde, North Carolina, United States

CaroMont Regional Medical Center

Gastonia, North Carolina, United States

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Cone Health Cancer Center

Greensboro, North Carolina, United States

AdventHealth Hendersonville

Hendersonville, North Carolina, United States

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, United States

CarolinaEast Medical Center

New Bern, North Carolina, United States

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, United States

Nash General Hospital

Rocky Mount, North Carolina, United States

NHRMC Radiation Oncology - Supply

Supply, North Carolina, United States

New Hanover Regional Medical Center/Zimmer Cancer Center

Wilmington, North Carolina, United States

Trinity Cancer Care Center

Minot, North Dakota, United States

Cleveland Clinic Akron General

Akron, Ohio, United States

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, United States

Kaiser Permanente Northwest

Portland, Oregon, United States

Phoenixville Hospital

Phoenixville, Pennsylvania, United States

Kent Hospital

Warwick, Rhode Island, United States

AnMed Health Cancer Center

Anderson, South Carolina, United States

Saint Joseph's/Candler - Bluffton Campus

Bluffton, South Carolina, United States

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

McLeod Regional Medical Center

Florence, South Carolina, United States

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, United States

Saint Francis Hospital