Breast Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

1336

Study ID:

NCT03939481

Recruitment Status:

Active, not recruiting

Sponsor:

SWOG Cancer Research Network

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 150 Locations for this study

See Locations Near You

Kaiser Permanente-Deer Valley Medical Center
Antioch California, 94531, United States
Kaiser Permanente Dublin
Dublin California, 94568, United States
Kaiser Permanente-Fremont
Fremont California, 94538, United States
Kaiser Permanente-Fresno
Fresno California, 93720, United States
Kaiser Permanente-Oakland
Oakland California, 94611, United States
Desert Regional Medical Center
Palm Springs California, 92262, United States
Kaiser Permanente-San Francisco
San Francisco California, 94115, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose California, 95119, United States
Kaiser Permanente San Leandro
San Leandro California, 94577, United States
Kaiser San Rafael-Gallinas
San Rafael California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara California, 95051, United States
Kaiser Permanente-Santa Rosa
Santa Rosa California, 95403, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville California, 95688, United States
Kaiser Permanente-Vallejo
Vallejo California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek California, 94596, United States
Rocky Mountain Regional VA Medical Center
Aurora Colorado, 80045, United States
Bayhealth Hospital Kent Campus
Dover Delaware, 19901, United States
Bayhealth Hospital Sussex Campus
Milford Delaware, 19963, United States
Florida Gynecologic Oncology
Fort Myers Florida, 33905, United States
Regional Cancer Center-Lee Memorial Health System
Fort Myers Florida, 33905, United States
Sacred Heart Hospital
Pensacola Florida, 32504, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah Georgia, 31405, United States
Hawaii Cancer Care - Savio
'Aiea Hawaii, 96701, United States
Pali Momi Medical Center
'Aiea Hawaii, 96701, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu Hawaii, 96813, United States
Kaiser Permanente Moanalua Medical Center
Honolulu Hawaii, 96819, United States
Kapiolani Medical Center for Women and Children
Honolulu Hawaii, 96826, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue Hawaii, 96766, United States
Centralia Oncology Clinic
Centralia Illinois, 62801, United States
Carle on Vermilion
Danville Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Carle Physician Group-Effingham
Effingham Illinois, 62401, United States
Crossroads Cancer Center
Effingham Illinois, 62401, United States
Little Company of Mary Hospital
Evergreen Park Illinois, 60805, United States
Edward Hines Jr VA Hospital
Hines Illinois, 60141, United States
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States
Trinity Medical Center
Moline Illinois, 61265, United States
Cancer Care Center of O'Fallon
O'Fallon Illinois, 62269, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
The Carle Foundation Hospital
Urbana Illinois, 61801, United States
McFarland Clinic PC - Ames
Ames Iowa, 50010, United States
Physicians' Clinic of Iowa PC
Cedar Rapids Iowa, 52402, United States
Mercy Hospital
Cedar Rapids Iowa, 52403, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids Iowa, 52403, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive Iowa, 50325, United States
Mercy Cancer Center-West Lakes
Clive Iowa, 50325, United States
Greater Regional Medical Center
Creston Iowa, 50801, United States
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States
Broadlawns Medical Center
Des Moines Iowa, 50314, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
Mercy Medical Center-West Lakes
West Des Moines Iowa, 50266, United States
HaysMed University of Kansas Health System
Hays Kansas, 67601, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Olathe Health Cancer Center
Olathe Kansas, 66061, United States
Salina Regional Health Center
Salina Kansas, 67401, United States
University of Kansas Health System Saint Francis Campus
Topeka Kansas, 66606, United States
Associates In Womens Health
Wichita Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas - Wichita
Wichita Kansas, 67214, United States
Flaget Memorial Hospital
Bardstown Kentucky, 40004, United States
Saint Joseph Hospital East
Lexington Kentucky, 40509, United States
Saint Joseph London
London Kentucky, 40741, United States
Louisiana State University Health Science Center
New Orleans Louisiana, 70112, United States
Tulane University Health Sciences Center
New Orleans Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans Louisiana, 70112, United States
LSU Health Sciences Center at Shreveport
Shreveport Louisiana, 71103, United States
Harold Alfond Center for Cancer Care
Augusta Maine, 04330, United States
Waldo County General Hospital
Belfast Maine, 04915, United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford Maine, 04005, United States
Penobscot Bay Medical Center
Rockport Maine, 04856, United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford Maine, 04073, United States
Maine Medical Center- Scarborough Campus
Scarborough Maine, 04074, United States
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States
University of Maryland Shore Medical Center at Easton
Easton Maryland, 21601, United States
Lahey Hospital and Medical Center
Burlington Massachusetts, 01805, United States
Winchester Hospital
Winchester Massachusetts, 01890, United States
Mercy Health Saint Mary's
Grand Rapids Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids Michigan, 49503, United States
Spectrum Health Reed City Hospital
Reed City Michigan, 49677, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
Metro Health Hospital
Wyoming Michigan, 49519, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Minnesota Oncology - Burnsville
Burnsville Minnesota, 55337, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Essentia Health - Deer River Clinic
Deer River Minnesota, 56636, United States
Essentia Health Cancer Center
Duluth Minnesota, 55805, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Unity Hospital
Fridley Minnesota, 55432, United States
Essentia Health Hibbing Clinic
Hibbing Minnesota, 55746, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States
Monticello Cancer Center
Monticello Minnesota, 55362, United States
North Memorial Medical Health Center
Robbinsdale Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Essentia Health Sandstone
Sandstone Minnesota, 55072, United States
Lakeview Hospital
Stillwater Minnesota, 55082, United States
Essentia Health Virginia Clinic
Virginia Minnesota, 55792, United States
Rice Memorial Hospital
Willmar Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury Minnesota, 55125, United States
Fairview Lakes Medical Center
Wyoming Minnesota, 55092, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla Missouri, 65401, United States
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
CHI Health Saint Francis
Grand Island Nebraska, 68803, United States
Saint Joseph Hospital
Nashua New Hampshire, 03060, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Randolph Hospital
Asheboro North Carolina, 27203, United States
AdventHealth Infusion Center Asheville
Asheville North Carolina, 28803, United States
Cone Health Cancer Center at Alamance Regional
Burlington North Carolina, 27215, United States
Southeastern Medical Oncology Center-Clinton
Clinton North Carolina, 28328, United States
AdventHealth Infusion Center Haywood
Clyde North Carolina, 28721, United States
CaroMont Regional Medical Center
Gastonia North Carolina, 28054, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro North Carolina, 27534, United States
Cone Health Cancer Center
Greensboro North Carolina, 27403, United States
AdventHealth Hendersonville
Hendersonville North Carolina, 28792, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville North Carolina, 28546, United States
CarolinaEast Medical Center
New Bern North Carolina, 28561, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst North Carolina, 28374, United States
Nash General Hospital
Rocky Mount North Carolina, 27804, United States
NHRMC Radiation Oncology - Supply
Supply North Carolina, 28462, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington North Carolina, 28401, United States
Trinity Cancer Care Center
Minot North Dakota, 58701, United States
Cleveland Clinic Akron General
Akron Ohio, 44307, United States
Good Samaritan Hospital - Cincinnati
Cincinnati Ohio, 45220, United States
Kaiser Permanente Northwest
Portland Oregon, 97227, United States
Phoenixville Hospital
Phoenixville Pennsylvania, 19460, United States
Kent Hospital
Warwick Rhode Island, 02886, United States
AnMed Health Cancer Center
Anderson South Carolina, 29621, United States
Saint Joseph's/Candler - Bluffton Campus
Bluffton South Carolina, 29910, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs South Carolina, 29316, United States
McLeod Regional Medical Center
Florence South Carolina, 29506, United States
Gibbs Cancer Center-Gaffney
Gaffney South Carolina, 29341, United States
Saint Francis Hospital
Greenville South Carolina, 29601, United States
Prisma Health Cancer Institute - Butternut
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville South Carolina, 29605, United States
Saint Francis Cancer Center
Greenville South Carolina, 29607, United States
Prisma Health Cancer Institute - Eastside
Greenville South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer South Carolina, 29651, United States
South Carolina Cancer Specialists PC
Hilton Head Island South Carolina, 29926, United States
Prisma Health Cancer Institute - Seneca
Seneca South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg South Carolina, 29303, United States
MGC Hematology Oncology-Union
Union South Carolina, 29379, United States
Cookeville Regional Medical Center
Cookeville Tennessee, 38501, United States
Ballad Health Cancer Care - Kingsport
Kingsport Tennessee, 37660, United States
UMC Cancer Center / UMC Health System
Lubbock Texas, 79415, United States
Texas Tech University Health Sciences Center-Lubbock
Lubbock Texas, 79430, United States
Wellmont Medical Associates-Bristol
Bristol Virginia, 24201, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville Virginia, 23116, United States
Bon Secours Saint Francis Medical Center
Midlothian Virginia, 23114, United States
Bon Secours Saint Mary's Hospital
Richmond Virginia, 23226, United States
Swedish Cancer Institute-Issaquah
Issaquah Washington, 98029, United States
Jefferson Healthcare
Port Townsend Washington, 98368, United States
Duluth Clinic Ashland
Ashland Wisconsin, 54806, United States
Cancer Center of Western Wisconsin
New Richmond Wisconsin, 54017, United States
Instituto Nacional del Cancer
Independence , 83804, Chile
Instituto Nacional De Cancerologia
Bogota , 99999, Colombia
Instituto Nacional De Cancerologia de Mexico
Mexico City Tlalpan, 14080, Mexico

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

1336

Study ID:

NCT03939481

Recruitment Status:

Active, not recruiting

Sponsor:


SWOG Cancer Research Network

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.