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Effetti del trattamento sullo sviluppo della neuropatia periferica indotta dalla chemioterapia nei pazienti con cancro

10 settembre 2026 aggiornato da: SWOG Cancer Research Network

Uno studio prospettico di coorte osservazionale per sviluppare un modello predittivo di neuropatia periferica indotta da taxani nei pazienti oncologici

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

1336

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Chile
- - Independence, Chile, 8380455
    - Instituto Nacional del Cancer
Colombia
- - Bogotá, Colombia, 99999
    - Instituto Nacional De Cancerologia
Messico
- Tlalpan
  - Mexico City, Tlalpan, Messico, 14080
    - Instituto Nacional De Cancerologia de Mexico
Stati Uniti
- California
  - Antioch, California, Stati Uniti, 94531
    - Kaiser Permanente-Deer Valley Medical Center
  - Dublin, California, Stati Uniti, 94568
    - Kaiser Permanente Dublin
  - Fremont, California, Stati Uniti, 94538
    - Kaiser Permanente-Fremont
  - Fresno, California, Stati Uniti, 93720
    - Kaiser Permanente-Fresno
  - Oakland, California, Stati Uniti, 94611
    - Kaiser Permanente-Oakland
  - Palm Springs, California, Stati Uniti, 92262
    - Desert Regional Medical Center
  - San Francisco, California, Stati Uniti, 94115
    - Kaiser Permanente-San Francisco
  - San Jose, California, Stati Uniti, 95119
    - Kaiser Permanente-Santa Teresa-San Jose
  - San Leandro, California, Stati Uniti, 94577
    - Kaiser Permanente San Leandro
  - San Rafael, California, Stati Uniti, 94903
    - Kaiser San Rafael-Gallinas
  - Santa Clara, California, Stati Uniti, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - Santa Rosa, California, Stati Uniti, 95403
    - Kaiser Permanente-Santa Rosa
  - Vacaville, California, Stati Uniti, 95688
    - Kaiser Permanente Medical Center-Vacaville
  - Vallejo, California, Stati Uniti, 94589
    - Kaiser Permanente-Vallejo
  - Walnut Creek, California, Stati Uniti, 94596
    - Kaiser Permanente-Walnut Creek
- Colorado
  - Aurora, Colorado, Stati Uniti, 80045
    - Rocky Mountain Regional VA Medical Center
- Delaware
  - Dover, Delaware, Stati Uniti, 19901
    - Bayhealth Hospital Kent Campus
  - Milford, Delaware, Stati Uniti, 19963
    - Bayhealth Hospital Sussex Campus
- Florida
  - Fort Myers, Florida, Stati Uniti, 33905
    - Regional Cancer Center-Lee Memorial Health System
  - Fort Myers, Florida, Stati Uniti, 33905
    - Florida Gynecologic Oncology
  - Pensacola, Florida, Stati Uniti, 32504
    - Sacred Heart Hospital
- Georgia
  - Savannah, Georgia, Stati Uniti, 31405
    - Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Hawaii
  - Honolulu, Hawaii, Stati Uniti, 96813
    - Hawaii Cancer Care Inc - Waterfront Plaza
  - Honolulu, Hawaii, Stati Uniti, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, Stati Uniti, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, Stati Uniti, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, Stati Uniti, 96819
    - Kaiser Permanente Moanalua Medical Center
  - Lihue, Hawaii, Stati Uniti, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
  - ‘Aiea, Hawaii, Stati Uniti, 96701
    - Pali Momi Medical Center
  - ‘Aiea, Hawaii, Stati Uniti, 96701
    - Hawaii Cancer Care - Savio
- Illinois
  - Centralia, Illinois, Stati Uniti, 62801
    - Centralia Oncology Clinic
  - Danville, Illinois, Stati Uniti, 61832
    - Carle on Vermilion
  - Decatur, Illinois, Stati Uniti, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, Stati Uniti, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Effingham, Illinois, Stati Uniti, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, Stati Uniti, 62401
    - Carle Physician Group-Effingham
  - Evergreen Park, Illinois, Stati Uniti, 60805
    - Little Company of Mary Hospital
  - Hines, Illinois, Stati Uniti, 60141
    - Edward Hines Jr VA Hospital
  - Mattoon, Illinois, Stati Uniti, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Moline, Illinois, Stati Uniti, 61265
    - Trinity Medical Center
  - O'Fallon, Illinois, Stati Uniti, 62269
    - Cancer Care Center of O'Fallon
  - Urbana, Illinois, Stati Uniti, 61801
    - Carle Cancer Center
  - Urbana, Illinois, Stati Uniti, 61801
    - The Carle Foundation Hospital
- Iowa
  - Ames, Iowa, Stati Uniti, 50010
    - McFarland Clinic PC - Ames
  - Cedar Rapids, Iowa, Stati Uniti, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, Stati Uniti, 52403
    - Oncology Associates at Mercy Medical Center
  - Cedar Rapids, Iowa, Stati Uniti, 52402
    - Physicians' Clinic of Iowa PC
  - Clive, Iowa, Stati Uniti, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, Stati Uniti, 50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - Creston, Iowa, Stati Uniti, 50801
    - Greater Regional Medical Center
  - Des Moines, Iowa, Stati Uniti, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, Stati Uniti, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Stati Uniti, 50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, Stati Uniti, 50314
    - Broadlawns Medical Center
  - Des Moines, Iowa, Stati Uniti, 50314
    - Medical Oncology and Hematology Associates-Laurel
  - West Des Moines, Iowa, Stati Uniti, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Hays, Kansas, Stati Uniti, 67601
    - HaysMed University of Kansas Health System
  - Lawrence, Kansas, Stati Uniti, 66044
    - Lawrence Memorial Hospital
  - Olathe, Kansas, Stati Uniti, 66061
    - Olathe Health Cancer Center
  - Salina, Kansas, Stati Uniti, 67401
    - Salina Regional Health Center
  - Topeka, Kansas, Stati Uniti, 66606
    - University of Kansas Health System Saint Francis Campus
  - Wichita, Kansas, Stati Uniti, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, Stati Uniti, 67214
    - Cancer Center of Kansas - Wichita
  - Wichita, Kansas, Stati Uniti, 67208
    - Associates In Womens Health
- Kentucky
  - Bardstown, Kentucky, Stati Uniti, 40004
    - Flaget Memorial Hospital
  - Lexington, Kentucky, Stati Uniti, 40509
    - Saint Joseph Hospital East
  - London, Kentucky, Stati Uniti, 40741
    - Saint Joseph London
- Louisiana
  - New Orleans, Louisiana, Stati Uniti, 70112
    - Tulane University Health Sciences Center
  - New Orleans, Louisiana, Stati Uniti, 70112
    - University Medical Center New Orleans
  - New Orleans, Louisiana, Stati Uniti, 70112
    - Louisiana State University Health Science Center
  - Shreveport, Louisiana, Stati Uniti, 71103
    - LSU Health Sciences Center at Shreveport
- Maine
  - Augusta, Maine, Stati Uniti, 04330
    - Harold Alfond Center for Cancer Care
  - Belfast, Maine, Stati Uniti, 04915
    - Waldo County General Hospital
  - Biddeford, Maine, Stati Uniti, 04005
    - MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
  - Rockport, Maine, Stati Uniti, 04856
    - Penobscot Bay Medical Center
  - Sanford, Maine, Stati Uniti, 04073
    - MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
  - Scarborough, Maine, Stati Uniti, 04074
    - Maine Medical Center- Scarborough Campus
- Maryland
  - Baltimore, Maryland, Stati Uniti, 21204
    - Greater Baltimore Medical Center
  - Easton, Maryland, Stati Uniti, 21601
    - University of Maryland Shore Medical Center at Easton
- Massachusetts
  - Burlington, Massachusetts, Stati Uniti, 01805
    - Lahey Hospital and Medical Center
  - Winchester, Massachusetts, Stati Uniti, 01890
    - Winchester Hospital
- Michigan
  - Grand Rapids, Michigan, Stati Uniti, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, Stati Uniti, 49503
    - Mercy Health Saint Mary's
  - Reed City, Michigan, Stati Uniti, 49677
    - Spectrum Health Reed City Hospital
  - Traverse City, Michigan, Stati Uniti, 49684
    - Munson Medical Center
  - Wyoming, Michigan, Stati Uniti, 49519
    - Metro Health Hospital
- Minnesota
  - Burnsville, Minnesota, Stati Uniti, 55337
    - Fairview Ridges Hospital
  - Burnsville, Minnesota, Stati Uniti, 55337
    - Minnesota Oncology - Burnsville
  - Coon Rapids, Minnesota, Stati Uniti, 55433
    - Mercy Hospital
  - Deer River, Minnesota, Stati Uniti, 56636
    - Essentia Health - Deer River Clinic
  - Duluth, Minnesota, Stati Uniti, 55805
    - Essentia Health Cancer Center
  - Edina, Minnesota, Stati Uniti, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, Stati Uniti, 55432
    - Unity Hospital
  - Hibbing, Minnesota, Stati Uniti, 55746
    - Essentia Health Hibbing Clinic
  - Maple Grove, Minnesota, Stati Uniti, 55369
    - Fairview Clinics and Surgery Center Maple Grove
  - Maplewood, Minnesota, Stati Uniti, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, Stati Uniti, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, Stati Uniti, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, Stati Uniti, 55407
    - Abbott-Northwestern Hospital
  - Monticello, Minnesota, Stati Uniti, 55362
    - Monticello Cancer Center
  - Robbinsdale, Minnesota, Stati Uniti, 55422
    - North Memorial Medical Health Center
  - Saint Louis Park, Minnesota, Stati Uniti, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, Stati Uniti, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, Stati Uniti, 55102
    - United Hospital
  - Sandstone, Minnesota, Stati Uniti, 55072
    - Essentia Health Sandstone
  - Stillwater, Minnesota, Stati Uniti, 55082
    - Lakeview Hospital
  - Virginia, Minnesota, Stati Uniti, 55792
    - Essentia Health Virginia Clinic
  - Willmar, Minnesota, Stati Uniti, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, Stati Uniti, 55125
    - Minnesota Oncology Hematology PA-Woodbury
  - Wyoming, Minnesota, Stati Uniti, 55092
    - Fairview Lakes Medical Center
- Missouri
  - Rolla, Missouri, Stati Uniti, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Springfield, Missouri, Stati Uniti, 65804
    - Mercy Hospital Springfield
  - St Louis, Missouri, Stati Uniti, 63131
    - Missouri Baptist Medical Center
- Nebraska
  - Grand Island, Nebraska, Stati Uniti, 68803
    - CHI Health Saint Francis
- New Hampshire
  - Nashua, New Hampshire, Stati Uniti, 03060
    - Saint Joseph Hospital
- New York
  - New York, New York, Stati Uniti, 10032
    - NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- North Carolina
  - Asheboro, North Carolina, Stati Uniti, 27203
    - Randolph Hospital
  - Asheville, North Carolina, Stati Uniti, 28803
    - AdventHealth Infusion Center Asheville
  - Burlington, North Carolina, Stati Uniti, 27215
    - Cone Health Cancer Center at Alamance Regional
  - Clinton, North Carolina, Stati Uniti, 28328
    - Southeastern Medical Oncology Center-Clinton
  - Clyde, North Carolina, Stati Uniti, 28721
    - AdventHealth Infusion Center Haywood
  - Gastonia, North Carolina, Stati Uniti, 28054
    - CaroMont Regional Medical Center
  - Goldsboro, North Carolina, Stati Uniti, 27534
    - Southeastern Medical Oncology Center-Goldsboro
  - Greensboro, North Carolina, Stati Uniti, 27403
    - Cone Health Cancer Center
  - Hendersonville, North Carolina, Stati Uniti, 28792
    - AdventHealth Hendersonville
  - Jacksonville, North Carolina, Stati Uniti, 28546
    - Southeastern Medical Oncology Center-Jacksonville
  - New Bern, North Carolina, Stati Uniti, 28561
    - CarolinaEast Medical Center
  - Pinehurst, North Carolina, Stati Uniti, 28374
    - FirstHealth of the Carolinas-Moore Regional Hospital
  - Rocky Mount, North Carolina, Stati Uniti, 27804
    - Nash General Hospital
  - Supply, North Carolina, Stati Uniti, 28462
    - NHRMC Radiation Oncology - Supply
  - Wilmington, North Carolina, Stati Uniti, 28401
    - New Hanover Regional Medical Center/Zimmer Cancer Center
- North Dakota
  - Minot, North Dakota, Stati Uniti, 58701
    - Trinity Cancer Care Center
- Ohio
  - Akron, Ohio, Stati Uniti, 44307
    - Cleveland Clinic Akron General
  - Cincinnati, Ohio, Stati Uniti, 45220
    - Good Samaritan Hospital - Cincinnati
- Oregon
  - Portland, Oregon, Stati Uniti, 97227
    - Kaiser Permanente Northwest
- Pennsylvania
  - Phoenixville, Pennsylvania, Stati Uniti, 19460
    - Phoenixville Hospital
- Rhode Island
  - Warwick, Rhode Island, Stati Uniti, 02886
    - Kent Hospital
- South Carolina
  - Anderson, South Carolina, Stati Uniti, 29621
    - AnMed Health Cancer Center
  - Bluffton, South Carolina, Stati Uniti, 29910
    - Saint Joseph's/Candler - Bluffton Campus
  - Boiling Springs, South Carolina, Stati Uniti, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Florence, South Carolina, Stati Uniti, 29506
    - McLeod Regional Medical Center
  - Gaffney, South Carolina, Stati Uniti, 29341
    - Gibbs Cancer Center-Gaffney
  - Greenville, South Carolina, Stati Uniti, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, Stati Uniti, 29607
    - Saint Francis Cancer Center
  - Greenville, South Carolina, Stati Uniti, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, Stati Uniti, 29605
    - Prisma Health Cancer Institute - Butternut
  - Greenville, South Carolina, Stati Uniti, 29601
    - Saint Francis Hospital
  - Greer, South Carolina, Stati Uniti, 29650
    - Prisma Health Cancer Institute - Greer
  - Greer, South Carolina, Stati Uniti, 29651
    - Gibbs Cancer Center-Pelham
  - Hilton Head Island, South Carolina, Stati Uniti, 29926-3827
    - South Carolina Cancer Specialists PC
  - Seneca, South Carolina, Stati Uniti, 29672
    - Prisma Health Cancer Institute - Seneca
  - Spartanburg, South Carolina, Stati Uniti, 29303
    - Spartanburg Medical Center
  - Union, South Carolina, Stati Uniti, 29379
    - MGC Hematology Oncology-Union
- Tennessee
  - Cookeville, Tennessee, Stati Uniti, 38501
    - Cookeville Regional Medical Center
  - Kingsport, Tennessee, Stati Uniti, 37660
    - Ballad Health Cancer Care - Kingsport
- Texas
  - Lubbock, Texas, Stati Uniti, 79415
    - UMC Cancer Center / UMC Health System
  - Lubbock, Texas, Stati Uniti, 79430
    - Texas Tech University Health Sciences Center-Lubbock
- Virginia
  - Bristol, Virginia, Stati Uniti, 24201
    - Wellmont Medical Associates-Bristol
  - Charlottesville, Virginia, Stati Uniti, 22908
    - University of Virginia Cancer Center
  - Mechanicsville, Virginia, Stati Uniti, 23116
    - Bon Secours Memorial Regional Medical Center
  - Midlothian, Virginia, Stati Uniti, 23114
    - Bon Secours Saint Francis Medical Center
  - Richmond, Virginia, Stati Uniti, 23226
    - Bon Secours Saint Mary's Hospital
- Washington
  - Issaquah, Washington, Stati Uniti, 98029
    - Swedish Cancer Institute-Issaquah
  - Port Townsend, Washington, Stati Uniti, 98368
    - Jefferson Healthcare
- Wisconsin
  - Ashland, Wisconsin, Stati Uniti, 54806
    - Duluth Clinic Ashland
  - New Richmond, Wisconsin, Stati Uniti, 54017
    - Cancer Center of Western Wisconsin

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Participants with stage I, II, or III primary non-small cell lung, primary breast, or primary ovarian cancer

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Modelli osservazionali: COHORT
Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte Gruppo / Coorte Un gruppo o sottogruppo di partecipanti a uno studio osservazionale che viene valutato per gli esiti biomedici o sanitari.	Intervento / Trattamento Intervento / Trattamento Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
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.	Droga: Chemotherapy Given chemotherapy regimen Altri nomi: Chemio Chemioterapia (NAS) Chemioterapia, Cancro, Generale Altro: Functional Assessment Functional and sensory clinician assessments Altro: Questionnaire Administration Patient and physician reported responses

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Number of Participants With Development of Peripheral Neuropathy Lasso di tempo: 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..	Up to 24 weeks

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
CIPN Symptoms Lasso di tempo: Up to 52 weeks	Patients experiencing a treatment change attributed to CIPN symptoms	Up to 52 weeks
Dose Changes Lasso di tempo: Up to 52 weeks	Dose reductions, delays, and discontinuations of treatment (prior to completing the original treatment plan)	Up to 52 weeks
Health-related Quality of Life Lasso di tempo: 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.	Up to 52 weeks
Visual Analog Toxicity Score Lasso di tempo: 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).	Up to 52 weeks
Patient Reported Symptom Lasso di tempo: 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]).	Up to 52 weeks
Leisure-time Exercise Habits Lasso di tempo: 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.	Up to 52 weeks
Patient-Reported Outcomes Lasso di tempo: 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".	Up to 52 weeks
National Cancer Institute-Common Terminology Criteria for Adverse Events Lasso di tempo: 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. Participants will only be graded for the event types listed above, so these will only be reported as an outcome measure, and will not appear in the adverse events section of this report.	Up to 52 weeks
Assess Incidence of CIPN Lasso di tempo: 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.	Up to 52 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

SWOG Cancer Research Network

Collaboratori

National Cancer Institute (NCI)

Investigatori

Investigatore principale: Meghna S Trivedi, SWOG Cancer Research Network

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 maggio 2019

Completamento primario (Effettivo)

8 aprile 2025

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

1 maggio 2019

Primo inviato che soddisfa i criteri di controllo qualità

3 maggio 2019

Primo Inserito (Effettivo)

6 maggio 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

S1714
UG1CA189974 (Sovvenzione/contratto NIH degli Stati Uniti)
S1714 (Altro identificatore: CTEP)
NCI-2018-01568 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
SWOG-S1714 (Altro identificatore: DCP)
S1714 (Altro identificatore: SWOG)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Effetti del trattamento sullo sviluppo della neuropatia periferica indotta dalla chemioterapia nei pazienti con cancro

Uno studio prospettico di coorte osservazionale per sviluppare un modello predittivo di neuropatia periferica indotta da taxani nei pazienti oncologici

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Tipo di studio

Iscrizione (Effettivo)

Contatti e Sedi

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Metodo di campionamento

Popolazione di studio

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di gruppi/coorti

Coorti e interventi

Gruppo / Coorte

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Collaboratori

Investigatori

Studiare le date dei record

Studia le date principali

Inizio studio (Effettivo)

Completamento primario (Effettivo)

Completamento dello studio (Stimato)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Effettivo)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio