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Brief Title: Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer
Official Title: A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane-Induced Peripheral Neuropathy in Cancer Patients
Study ID: NCT03939481
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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 - Savio, 'Aiea, Hawaii, United States
Pali Momi Medical Center, 'Aiea, Hawaii, 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
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
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, 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, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Saint Francis Cancer Center, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Gibbs Cancer Center-Pelham, Greer, South Carolina, United States
South Carolina Cancer Specialists PC, Hilton Head Island, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
MGC Hematology Oncology-Union, Union, South Carolina, United States
Cookeville Regional Medical Center, Cookeville, Tennessee, United States
Ballad Health Cancer Care - Kingsport, Kingsport, Tennessee, United States
UMC Cancer Center / UMC Health System, Lubbock, Texas, United States
Texas Tech University Health Sciences Center-Lubbock, Lubbock, Texas, United States
Wellmont Medical Associates-Bristol, Bristol, Virginia, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Bon Secours Memorial Regional Medical Center, Mechanicsville, Virginia, United States
Bon Secours Saint Francis Medical Center, Midlothian, Virginia, United States
Bon Secours Saint Mary's Hospital, Richmond, Virginia, United States
Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States
Jefferson Healthcare, Port Townsend, Washington, United States
Duluth Clinic Ashland, Ashland, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Instituto Nacional del Cancer, Independence, , Chile
Instituto Nacional De Cancerologia, Bogota, , Colombia
Instituto Nacional De Cancerologia de Mexico, Mexico City, Tlalpan, Mexico
Name: Meghna S Trivedi
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR