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.
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.
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.
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There are 150 Locations for this study
Antioch California, 94531, United States
Dublin California, 94568, United States
Fremont California, 94538, United States
Fresno California, 93720, United States
Oakland California, 94611, United States
Palm Springs California, 92262, United States
San Francisco California, 94115, United States
San Jose California, 95119, United States
San Leandro California, 94577, United States
San Rafael California, 94903, United States
Santa Clara California, 95051, United States
Santa Rosa California, 95403, United States
Vacaville California, 95688, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Aurora Colorado, 80045, United States
Dover Delaware, 19901, United States
Milford Delaware, 19963, United States
Fort Myers Florida, 33905, United States
Fort Myers Florida, 33905, United States
Pensacola Florida, 32504, United States
Savannah Georgia, 31405, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96819, United States
Honolulu Hawaii, 96826, United States
Lihue Hawaii, 96766, United States
Centralia Illinois, 62801, United States
Danville Illinois, 61832, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Effingham Illinois, 62401, United States
Effingham Illinois, 62401, United States
Evergreen Park Illinois, 60805, United States
Hines Illinois, 60141, United States
Mattoon Illinois, 61938, United States
Moline Illinois, 61265, United States
O'Fallon Illinois, 62269, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Ames Iowa, 50010, United States
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Iowa, 52403, United States
Cedar Rapids Iowa, 52403, United States
Clive Iowa, 50325, United States
Clive Iowa, 50325, United States
Creston Iowa, 50801, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
West Des Moines Iowa, 50266, United States
Hays Kansas, 67601, United States
Lawrence Kansas, 66044, United States
Olathe Kansas, 66061, United States
Salina Kansas, 67401, United States
Topeka Kansas, 66606, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Bardstown Kentucky, 40004, United States
Lexington Kentucky, 40509, United States
London Kentucky, 40741, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
Shreveport Louisiana, 71103, United States
Augusta Maine, 04330, United States
Belfast Maine, 04915, United States
Biddeford Maine, 04005, United States
Rockport Maine, 04856, United States
Sanford Maine, 04073, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21204, United States
Easton Maryland, 21601, United States
Burlington Massachusetts, 01805, United States
Winchester Massachusetts, 01890, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Reed City Michigan, 49677, United States
Traverse City Michigan, 49684, United States
Wyoming Michigan, 49519, United States
Burnsville Minnesota, 55337, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Deer River Minnesota, 56636, United States
Duluth Minnesota, 55805, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hibbing Minnesota, 55746, United States
Maple Grove Minnesota, 55369, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Monticello Minnesota, 55362, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Sandstone Minnesota, 55072, United States
Stillwater Minnesota, 55082, United States
Virginia Minnesota, 55792, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Wyoming Minnesota, 55092, United States
Rolla Missouri, 65401, United States
Saint Louis Missouri, 63131, United States
Springfield Missouri, 65804, United States
Grand Island Nebraska, 68803, United States
Nashua New Hampshire, 03060, United States
New York New York, 10032, United States
Asheboro North Carolina, 27203, United States
Asheville North Carolina, 28803, United States
Burlington North Carolina, 27215, United States
Clinton North Carolina, 28328, United States
Clyde North Carolina, 28721, United States
Gastonia North Carolina, 28054, United States
Goldsboro North Carolina, 27534, United States
Greensboro North Carolina, 27403, United States
Hendersonville North Carolina, 28792, United States
Jacksonville North Carolina, 28546, United States
New Bern North Carolina, 28561, United States
Pinehurst North Carolina, 28374, United States
Rocky Mount North Carolina, 27804, United States
Supply North Carolina, 28462, United States
Wilmington North Carolina, 28401, United States
Minot North Dakota, 58701, United States
Akron Ohio, 44307, United States
Cincinnati Ohio, 45220, United States
Portland Oregon, 97227, United States
Phoenixville Pennsylvania, 19460, United States
Warwick Rhode Island, 02886, United States
Anderson South Carolina, 29621, United States
Bluffton South Carolina, 29910, United States
Boiling Springs South Carolina, 29316, United States
Florence South Carolina, 29506, United States
Gaffney South Carolina, 29341, United States
Greenville South Carolina, 29601, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29607, United States
Greenville South Carolina, 29615, United States
Greer South Carolina, 29650, United States
Greer South Carolina, 29651, United States
Hilton Head Island South Carolina, 29926, United States
Seneca South Carolina, 29672, United States
Spartanburg South Carolina, 29303, United States
Union South Carolina, 29379, United States
Cookeville Tennessee, 38501, United States
Kingsport Tennessee, 37660, United States
Lubbock Texas, 79415, United States
Lubbock Texas, 79430, United States
Bristol Virginia, 24201, United States
Charlottesville Virginia, 22908, United States
Mechanicsville Virginia, 23116, United States
Midlothian Virginia, 23114, United States
Richmond Virginia, 23226, United States
Issaquah Washington, 98029, United States
Port Townsend Washington, 98368, United States
Ashland Wisconsin, 54806, United States
New Richmond Wisconsin, 54017, United States
Independence , 83804, Chile
Bogota , 99999, Colombia
Mexico City Tlalpan, 14080, Mexico
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