Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial
Official title:
A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane-Induced Peripheral Neuropathy in Cancer Patients
Verified date | June 2024 |
Source | SWOG Cancer Research Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 1336 |
Est. completion date | February 28, 2026 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Chile | Instituto Nacional del Cancer | Independence | |
Colombia | Instituto Nacional De Cancerologia | Bogota | |
Mexico | Instituto Nacional De Cancerologia de Mexico | Mexico City | Tlalpan |
United States | Hawaii Cancer Care - Savio | 'Aiea | Hawaii |
United States | Pali Momi Medical Center | 'Aiea | Hawaii |
United States | Cleveland Clinic Akron General | Akron | Ohio |
United States | McFarland Clinic PC - Ames | Ames | Iowa |
United States | AnMed Health Cancer Center | Anderson | South Carolina |
United States | Kaiser Permanente-Deer Valley Medical Center | Antioch | California |
United States | Randolph Hospital | Asheboro | North Carolina |
United States | AdventHealth Infusion Center Asheville | Asheville | North Carolina |
United States | Duluth Clinic Ashland | Ashland | Wisconsin |
United States | Harold Alfond Center for Cancer Care | Augusta | Maine |
United States | Rocky Mountain Regional VA Medical Center | Aurora | Colorado |
United States | Greater Baltimore Medical Center | Baltimore | Maryland |
United States | Flaget Memorial Hospital | Bardstown | Kentucky |
United States | Waldo County General Hospital | Belfast | Maine |
United States | MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford | Biddeford | Maine |
United States | Saint Joseph's/Candler - Bluffton Campus | Bluffton | South Carolina |
United States | Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina |
United States | Wellmont Medical Associates-Bristol | Bristol | Virginia |
United States | Cone Health Cancer Center at Alamance Regional | Burlington | North Carolina |
United States | Lahey Hospital and Medical Center | Burlington | Massachusetts |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Minnesota Oncology - Burnsville | Burnsville | Minnesota |
United States | Mercy Hospital | Cedar Rapids | Iowa |
United States | Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa |
United States | Physicians' Clinic of Iowa PC | Cedar Rapids | Iowa |
United States | Centralia Oncology Clinic | Centralia | Illinois |
United States | University of Virginia Cancer Center | Charlottesville | Virginia |
United States | Good Samaritan Hospital - Cincinnati | Cincinnati | Ohio |
United States | Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina |
United States | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa |
United States | Mercy Cancer Center-West Lakes | Clive | Iowa |
United States | AdventHealth Infusion Center Haywood | Clyde | North Carolina |
United States | Cookeville Regional Medical Center | Cookeville | Tennessee |
United States | Mercy Hospital | Coon Rapids | Minnesota |
United States | Greater Regional Medical Center | Creston | Iowa |
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 | Essentia Health - Deer River Clinic | Deer River | Minnesota |
United States | Broadlawns Medical Center | Des Moines | Iowa |
United States | Iowa Methodist Medical Center | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates-Des Moines | 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 | Bayhealth Hospital Kent Campus | Dover | Delaware |
United States | Kaiser Permanente Dublin | Dublin | California |
United States | Essentia Health Cancer Center | Duluth | Minnesota |
United States | University of Maryland Shore Medical Center at Easton | Easton | Maryland |
United States | Fairview Southdale Hospital | Edina | Minnesota |
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 | McLeod Regional Medical Center | Florence | South Carolina |
United States | Florida Gynecologic Oncology | Fort Myers | Florida |
United States | Regional Cancer Center-Lee Memorial Health System | Fort Myers | Florida |
United States | Kaiser Permanente-Fremont | Fremont | California |
United States | Kaiser Permanente-Fresno | Fresno | California |
United States | Unity Hospital | Fridley | Minnesota |
United States | Gibbs Cancer Center-Gaffney | Gaffney | South Carolina |
United States | CaroMont Regional Medical Center | Gastonia | North Carolina |
United States | Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina |
United States | CHI Health Saint Francis | Grand Island | Nebraska |
United States | Mercy Health Saint Mary's | Grand Rapids | Michigan |
United States | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan |
United States | Cone Health Cancer Center | Greensboro | North Carolina |
United States | Prisma Health Cancer Institute - Butternut | Greenville | South Carolina |
United States | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina |
United States | Prisma Health Cancer Institute - Faris | Greenville | South Carolina |
United States | Saint Francis Cancer Center | Greenville | South Carolina |
United States | Saint Francis Hospital | Greenville | South Carolina |
United States | Gibbs Cancer Center-Pelham | Greer | South Carolina |
United States | Prisma Health Cancer Institute - Greer | Greer | South Carolina |
United States | HaysMed University of Kansas Health System | Hays | Kansas |
United States | AdventHealth Hendersonville | Hendersonville | North Carolina |
United States | Essentia Health Hibbing Clinic | Hibbing | Minnesota |
United States | South Carolina Cancer Specialists PC | Hilton Head Island | South Carolina |
United States | Edward Hines Jr VA Hospital | Hines | Illinois |
United States | Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii |
United States | Kaiser Permanente Moanalua Medical Center | Honolulu | Hawaii |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Straub Clinic and Hospital | Honolulu | Hawaii |
United States | University of Hawaii Cancer Center | Honolulu | Hawaii |
United States | Swedish Cancer Institute-Issaquah | Issaquah | Washington |
United States | Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina |
United States | Ballad Health Cancer Care - Kingsport | Kingsport | Tennessee |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Saint Joseph Hospital East | Lexington | Kentucky |
United States | Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii |
United States | Saint Joseph London | London | Kentucky |
United States | Texas Tech University Health Sciences Center-Lubbock | Lubbock | Texas |
United States | UMC Cancer Center / UMC Health System | Lubbock | Texas |
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 | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois |
United States | Bon Secours Memorial Regional Medical Center | Mechanicsville | Virginia |
United States | Bon Secours Saint Francis Medical Center | Midlothian | Virginia |
United States | Bayhealth Hospital Sussex Campus | Milford | Delaware |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Trinity Cancer Care Center | Minot | North Dakota |
United States | Trinity Medical Center | Moline | Illinois |
United States | Monticello Cancer Center | Monticello | Minnesota |
United States | Saint Joseph Hospital | Nashua | New Hampshire |
United States | CarolinaEast Medical Center | New Bern | North Carolina |
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 | Cancer Center of Western Wisconsin | New Richmond | Wisconsin |
United States | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | Cancer Care Center of O'Fallon | O'Fallon | Illinois |
United States | Kaiser Permanente-Oakland | Oakland | California |
United States | Olathe Health Cancer Center | Olathe | Kansas |
United States | Desert Regional Medical Center | Palm Springs | California |
United States | Sacred Heart Hospital | Pensacola | Florida |
United States | Phoenixville Hospital | Phoenixville | Pennsylvania |
United States | FirstHealth of the Carolinas-Moore Regional Hospital | Pinehurst | North Carolina |
United States | Jefferson Healthcare | Port Townsend | Washington |
United States | Kaiser Permanente Northwest | Portland | Oregon |
United States | Spectrum Health Reed City Hospital | Reed City | Michigan |
United States | Bon Secours Saint Mary's Hospital | Richmond | Virginia |
United States | North Memorial Medical Health Center | Robbinsdale | Minnesota |
United States | Penobscot Bay Medical Center | Rockport | Maine |
United States | Nash General Hospital | Rocky Mount | North Carolina |
United States | Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
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 | Salina Regional Health Center | Salina | Kansas |
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 | Essentia Health Sandstone | Sandstone | Minnesota |
United States | MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford | Sanford | Maine |
United States | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California |
United States | Kaiser Permanente-Santa Rosa | Santa Rosa | California |
United States | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia |
United States | Maine Medical Center- Scarborough Campus | Scarborough | Maine |
United States | Prisma Health Cancer Institute - Seneca | Seneca | South Carolina |
United States | LSU Health Sciences Center at Shreveport | Shreveport | Louisiana |
United States | Spartanburg Medical Center | Spartanburg | South Carolina |
United States | Mercy Hospital Springfield | Springfield | Missouri |
United States | Lakeview Hospital | Stillwater | Minnesota |
United States | NHRMC Radiation Oncology - Supply | Supply | North Carolina |
United States | University of Kansas Health System Saint Francis Campus | Topeka | Kansas |
United States | Munson Medical Center | Traverse City | Michigan |
United States | MGC Hematology Oncology-Union | Union | South Carolina |
United States | Carle Cancer Center | Urbana | Illinois |
United States | The Carle Foundation Hospital | Urbana | Illinois |
United States | Kaiser Permanente Medical Center-Vacaville | Vacaville | California |
United States | Kaiser Permanente-Vallejo | Vallejo | California |
United States | Essentia Health Virginia Clinic | Virginia | Minnesota |
United States | Kaiser Permanente-Walnut Creek | Walnut Creek | California |
United States | Kent Hospital | Warwick | Rhode Island |
United States | Mercy Medical Center-West Lakes | West Des Moines | Iowa |
United States | Associates In Womens Health | Wichita | Kansas |
United States | Cancer Center of Kansas - Wichita | Wichita | Kansas |
United States | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas |
United States | Rice Memorial Hospital | Willmar | Minnesota |
United States | New Hanover Regional Medical Center/Zimmer Cancer Center | Wilmington | North Carolina |
United States | Winchester Hospital | Winchester | Massachusetts |
United States | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota |
United States | Fairview Lakes Medical Center | Wyoming | Minnesota |
United States | Metro Health Hospital | Wyoming | Michigan |
Lead Sponsor | Collaborator |
---|---|
SWOG Cancer Research Network | National Cancer Institute (NCI) |
United States, Chile, Colombia, Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 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. | Up to 24 weeks | |
Secondary | CIPN symptoms | Patients experiencing a treatment change attributed to CIPN symptoms | Up to 52 weeks | |
Secondary | Dose Changes | Dose reductions, delays, and discontinuations of treatment (prior to completing the original treatment plan) | Up to 52 weeks | |
Secondary | Health-related Quality of Life | 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. | Up to 52 weeks | |
Secondary | Visual Analog Toxicity Score | 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). | Up to 52 weeks | |
Secondary | Patient Reported Symptom | 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]). | Up to 52 weeks | |
Secondary | Leisure-time Exercise Habits | 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. | Up to 52 weeks | |
Secondary | Patient-Reported Outcomes | 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". | Up to 52 weeks | |
Secondary | National Cancer Institute-Common Terminology Criteria for Adverse Events | 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. | Up to 52 weeks | |
Secondary | Assess incidence of CIPN | 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. | Up to 52 weeks |
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