Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer
- Conditions
- Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8
- Interventions
- Drug: ChemotherapyOther: Functional AssessmentOther: Questionnaire Administration
- Registration Number
- NCT03939481
- Lead Sponsor
- SWOG Cancer Research Network
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1336
-
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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational (non-study chemo, questionnaire, assessments) Chemotherapy 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. Observational (non-study chemo, questionnaire, assessments) Functional Assessment 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. Observational (non-study chemo, questionnaire, assessments) Questionnaire Administration 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.
- Primary Outcome Measures
Name Time Method Development of peripheral neuropathy Up to 24 weeks 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 as the taxane-based chemotherapy regimens in this study are expected to be completed within 8 to 18 weeks. The presence of CIPN will be captured at 52 weeks to evaluate the duration of neuropathy which is anticipated to wane after treatment discontinuation.
- Secondary Outcome Measures
Name Time Method Visual Analog Toxicity Score Up to 52 weeks Assessed using the Visual Analog Toxicity Score. The Visual Analog Toxicity Score is a single question asking the physician to rate how the physician feels the patient's disease and treatment affects their daily life on a scale from 0 (no symptoms and no effect on life) to 10 (severe effects of treatment and patient would rather be dead).
CIPN symptoms Up to 52 weeks Patients experiencing a treatment change attributed to CIPN symptoms
Leisure-time Exercise Habits Up to 52 weeks Assessed using the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ). The GSLTPAQ is a brief 4 item self-administered questionnaire of usual leisure-time exercise habits over a typical 7-day period. The Leisure Score Index (LSI) is calculated based on the first 3 questions. The LSI scores can be used to classify respondents into active (LSI \> 24) and insufficiently active (LSI \< 23) categories.
Patient-Reported Outcomes Up to 52 weeks Assessed using the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE \[CTCAE Version 5.0\]). PRO-CTCAE assesses 78 adverse events by self-report with 124 items. Each item uses a plain language term for the adverse event, the attribute of interest, and the standard recall period of "the past 7 days".
Dose Changes Up to 52 weeks Dose reductions, delays, and discontinuations of treatment (prior to completing the original treatment plan)
Health-related Quality of Life Up to 52 weeks Assessed using the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29). The PROMIS-29 is a well validated assessment tool that offers both qualitative and quantitative measures of health-related quality of life. The PROMIS-29 includes 29 questions evaluating areas of physical function, anxiety, depression, fatigue, sleep, social functioning, and pain interference. The PROMIS-29 assesses severity levels of symptoms and their effect on the patient's functioning.
Patient Reported Symptom Up to 52 weeks Assessed using the Patient Reported Symptom Burden Score. The Patient Reported Symptom Score at baseline contains one question to assess how cancer symptoms affect the patient's life (scale 0 \[no burden at all\] to 10 \[a great burden\]). At follow-up, the Symptom Burden Score contains five questions: 1) to assess burden of side effects of cancer treatment on life (scale 0 \[no burden at all\] to 10 \[a great burden\]), 2) to assess severity of side effects from cancer treatment (scale 0 \[no side effects\]) to 10 \[side effects extremely severe and unbearable\]), 3) to assess tolerability of side effects for set time periods (yes/no), 4) to assess level at which treatment would be considered intolerable (scale 0 \[side effects not severe at all\] to 10 \[side effects extremely severe and unbearable\]), and 5) to assess the burden of cancer symptoms and treatment symptoms (scale 0 \[no burden at all\] to 10 \[a great burden\]).
National Cancer Institute-Common Terminology Criteria for Adverse Events Up to 52 weeks The NCI-CTCAE is a subjective method to evaluate CIPN performed by a healthcare professional. The treating physician will grade the subject's dysesthesia, paresthesia, neuralgia, peripheral sensory neuropathy, and peripheral motor neuropathy on a scale of 0 to 5 depending on the severity. The advantage of the NCI-CTCAE is that the assessment is quick and easy for providers to perform, (8) but it is limited by the subjectivity of interpretation, lack of detail about location, type, and severity of impairment, and narrow scoring range.
Assess incidence of CIPN Up to 52 weeks Assessed using European Organization for Research and Treatment of Cancer (EORTC) QLQ-CIPN20 (CIPN-20). The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning with each item measured on a 1-4 scale (1, not at all; 4, very much). The sensory subscale raw scores range from 1 to 36. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms.
Trial Locations
- Locations (168)
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Carle Physician Group-Mattoon/Charleston
🇺🇸Mattoon, Illinois, United States
Maine Medical Center- Scarborough Campus
🇺🇸Scarborough, Maine, United States
Cancer Care Center of O'Fallon
🇺🇸O'Fallon, Illinois, United States
Kaiser San Rafael-Gallinas
🇺🇸San Rafael, California, United States
Mercy Clinic-Rolla-Cancer and Hematology
🇺🇸Rolla, Missouri, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Flaget Memorial Hospital
🇺🇸Bardstown, Kentucky, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
FirstHealth of the Carolinas-Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
Southeastern Medical Oncology Center-Jacksonville
🇺🇸Jacksonville, North Carolina, United States
AnMed Health Cancer Center
🇺🇸Anderson, South Carolina, United States
Gibbs Cancer Center-Gaffney
🇺🇸Gaffney, South Carolina, United States
Prisma Health Cancer Institute - Butternut
🇺🇸Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
🇺🇸Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer
🇺🇸Greer, South Carolina, United States
McLeod Regional Medical Center
🇺🇸Florence, South Carolina, United States
Saint Francis Hospital
🇺🇸Greenville, South Carolina, United States
Saint Francis Cancer Center
🇺🇸Greenville, 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
Prisma Health Cancer Institute - Eastside
🇺🇸Greenville, South Carolina, United States
Cookeville Regional Medical Center
🇺🇸Cookeville, Tennessee, United States
Ballad Health Cancer Care - Kingsport
🇺🇸Kingsport, Tennessee, United States
Cancer Center of Western Wisconsin
🇺🇸New Richmond, Wisconsin, United States
Kaiser Permanente-San Francisco
🇺🇸San Francisco, California, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Good Samaritan Hospital - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Salina Regional Health Center
🇺🇸Salina, Kansas, United States
North Memorial Medical Health Center
🇺🇸Robbinsdale, Minnesota, United States
Pali Momi Medical Center
🇺🇸'Aiea, Hawaii, United States
Essentia Health Cancer Center
🇺🇸Duluth, Minnesota, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
🇺🇸Lihue, Hawaii, United States
HaysMed University of Kansas Health System
🇺🇸Hays, Kansas, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Olathe Health Cancer Center
🇺🇸Olathe, Kansas, United States
Fairview Clinics and Surgery Center Maple Grove
🇺🇸Maple Grove, Minnesota, United States
Essentia Health - Deer River Clinic
🇺🇸Deer River, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
🇺🇸Woodbury, Minnesota, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Essentia Health Sandstone
🇺🇸Sandstone, Minnesota, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Unity Hospital
🇺🇸Fridley, Minnesota, United States
Fairview Lakes Medical Center
🇺🇸Wyoming, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
🇺🇸Saint Louis Park, Minnesota, United States
Saint John's Hospital - Healtheast
🇺🇸Maplewood, Minnesota, United States
Lakeview Hospital
🇺🇸Stillwater, Minnesota, United States
Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Essentia Health Virginia Clinic
🇺🇸Virginia, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Trinity Cancer Care Center
🇺🇸Minot, North Dakota, United States
Bayhealth Hospital Sussex Campus
🇺🇸Milford, Delaware, United States
Florida Gynecologic Oncology
🇺🇸Fort Myers, Florida, United States
Cancer Care Specialists of Illinois - Decatur
🇺🇸Decatur, Illinois, United States
Kaiser Permanente-Oakland
🇺🇸Oakland, California, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Swedish Cancer Institute-Issaquah
🇺🇸Issaquah, Washington, United States
Jefferson Healthcare
🇺🇸Port Townsend, Washington, United States
Kaiser Permanente Northwest
🇺🇸Portland, Oregon, United States
Rocky Mountain Regional VA Medical Center
🇺🇸Aurora, Colorado, United States
Kaiser Permanente-Deer Valley Medical Center
🇺🇸Antioch, California, United States
Desert Regional Medical Center
🇺🇸Palm Springs, 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-Santa Teresa-San Jose
🇺🇸San Jose, California, United States
Kaiser Permanente San Leandro
🇺🇸San Leandro, 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-Vallejo
🇺🇸Vallejo, California, United States
Kaiser Permanente Medical Center-Vacaville
🇺🇸Vacaville, California, United States
Kaiser Permanente-Walnut Creek
🇺🇸Walnut Creek, California, United States
Bayhealth Hospital Kent Campus
🇺🇸Dover, Delaware, United States
Regional Cancer Center-Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Hawaii Cancer Care - Savio
🇺🇸'Aiea, Hawaii, United States
Carle on Vermilion
🇺🇸Danville, Illinois, United States
Centralia Oncology Clinic
🇺🇸Centralia, 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
Trinity Medical Center
🇺🇸Moline, 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
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
Mercy Medical Center-West Lakes
🇺🇸West Des Moines, Iowa, United States
University of Kansas Health System Saint Francis Campus
🇺🇸Topeka, Kansas, United States
Saint Joseph London
🇺🇸London, Kentucky, United States
LSU Health Sciences Center at Shreveport
🇺🇸Shreveport, Louisiana, United States
Harold Alfond Center for Cancer Care
🇺🇸Augusta, Maine, United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
🇺🇸Biddeford, Maine, United States
Waldo County General Hospital
🇺🇸Belfast, Maine, United States
Penobscot Bay Medical Center
🇺🇸Rockport, Maine, United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
🇺🇸Sanford, Maine, United States
University of Maryland Shore Medical Center at Easton
🇺🇸Easton, Maryland, United States
Winchester Hospital
🇺🇸Winchester, Massachusetts, United States
Mercy Health Saint Mary's
🇺🇸Grand Rapids, Michigan, United States
Spectrum Health Reed City Hospital
🇺🇸Reed City, Michigan, United States
Spectrum Health at Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Minnesota Oncology - Burnsville
🇺🇸Burnsville, Minnesota, United States
Essentia Health Hibbing Clinic
🇺🇸Hibbing, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
🇺🇸Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Monticello Cancer Center
🇺🇸Monticello, Minnesota, United States
Saint Joseph Hospital
🇺🇸Nashua, New Hampshire, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
CHI Health Saint Francis
🇺🇸Grand Island, Nebraska, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, 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
Southeastern Medical Oncology Center-Clinton
🇺🇸Clinton, 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
CaroMont Regional Medical Center
🇺🇸Gastonia, North Carolina, United States
Cone Health Cancer Center
🇺🇸Greensboro, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
🇺🇸Goldsboro, North Carolina, United States
AdventHealth Infusion Center Haywood
🇺🇸Clyde, North Carolina, United States
AdventHealth Hendersonville
🇺🇸Hendersonville, North Carolina, United States
CarolinaEast Medical Center
🇺🇸New Bern, 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
Cleveland Clinic Akron General
🇺🇸Akron, Ohio, United States
Phoenixville Hospital
🇺🇸Phoenixville, Pennsylvania, United States
Kent Hospital
🇺🇸Warwick, Rhode Island, United States
Prisma Health Cancer Institute - Spartanburg
🇺🇸Boiling Springs, South Carolina, United States
Saint Joseph's/Candler - Bluffton Campus
🇺🇸Bluffton, South Carolina, United States
South Carolina Cancer Specialists PC
🇺🇸Hilton Head Island, South Carolina, United States
Gibbs Cancer Center-Pelham
🇺🇸Greer, South Carolina, United States
UMC Cancer Center / UMC Health System
🇺🇸Lubbock, Texas, United States
Wellmont Medical Associates-Bristol
🇺🇸Bristol, Virginia, United States
Texas Tech University Health Sciences Center-Lubbock
🇺🇸Lubbock, Texas, United States
Bon Secours Saint Francis Medical Center
🇺🇸Midlothian, Virginia, United States
Bon Secours Memorial Regional Medical Center
🇺🇸Mechanicsville, Virginia, United States
Duluth Clinic Ashland
🇺🇸Ashland, 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
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
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
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
Saint Joseph Hospital East
🇺🇸Lexington, 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
Bon Secours Saint Mary's Hospital
🇺🇸Richmond, Virginia, United States