Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer
A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane-Induced Peripheral Neuropathy in Cancer Patients
4 other identifiers
observational
1,336
4 countries
169
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Longer than P75 for all trials
169 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedStudy Start
First participant enrolled
May 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2025
CompletedResults Posted
Study results publicly available
June 8, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedJune 8, 2026
April 1, 2026
5.9 years
May 1, 2019
April 21, 2026
June 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Development of Peripheral Neuropathy
Will be measured as an absolute increase of \>= 8 points over the baseline chemotherapy-induced peripheral neuropathy (CIPN)-20 sensory neuropathy subscale score. Will be collected before or at the 24-week assessment..
Up to 24 weeks
Secondary Outcomes (9)
CIPN Symptoms
Up to 52 weeks
Dose Changes
Up to 52 weeks
Health-related Quality of Life
Up to 52 weeks
Visual Analog Toxicity Score
Up to 52 weeks
Patient Reported Symptom
Up to 52 weeks
- +4 more secondary outcomes
Study Arms (1)
Observational (non-study chemo, questionnaire, assessments)
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.
Interventions
Given chemotherapy regimen
Functional and sensory clinician assessments
Patient and physician reported responses
Eligibility Criteria
Participants with stage I, II, or III primary non-small cell lung, primary breast, or primary ovarian cancer
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SWOG Cancer Research Networklead
- National Cancer Institute (NCI)collaborator
Study Sites (169)
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 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
Hawaii Cancer Care - Savio
‘Aiea, Hawaii, 96701, United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701, 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
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, 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, 29926-3827, 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, 8380455, Chile
Instituto Nacional De Cancerologia
Bogotá, 99999, Colombia
Instituto Nacional De Cancerologia de Mexico
Mexico City, Tlalpan, 14080, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
These data generalize best to female patients with breast cancer. Limited data were available to guide the determination of a clinically meaningful difference in TIPN rates based on baseline clinical factors alone at the time of trial design. While a count of risk factors improves model usability for clinicians, it may degrade model performance.
Results Point of Contact
- Title
- Amy Darke
- Organization
- Fred Hutchinson Cancer Research Center
Study Officials
- PRINCIPAL INVESTIGATOR
Meghna S Trivedi
SWOG Cancer Research Network
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2019
First Posted
May 6, 2019
Study Start
May 14, 2019
Primary Completion
April 8, 2025
Study Completion (Estimated)
September 1, 2026
Last Updated
June 8, 2026
Results First Posted
June 8, 2026
Record last verified: 2026-04