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Efectos del tratamiento sobre el desarrollo de neuropatía periférica inducida por quimioterapia en pacientes con cáncer

10 de septiembre de 2026 actualizado por: SWOG Cancer Research Network

Un estudio de cohorte observacional prospectivo para desarrollar un modelo predictivo de neuropatía periférica inducida por taxanos en pacientes con cáncer

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.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

De observación

Inscripción (Actual)

1336

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: COHORT
  • Perspectivas temporales: PROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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

Otros nombres:
  • Quimioterapia
  • Quimioterapia (NOS)
  • Quimioterapia, Cáncer, General
Otro: Functional Assessment

Functional and sensory clinician assessments

Otro: Questionnaire Administration

Patient and physician reported responses

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Development of Peripheral Neuropathy
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
CIPN Symptoms
Periodo de tiempo: Up to 52 weeks

Patients experiencing a treatment change attributed to CIPN symptoms
Up to 52 weeks
Dose Changes
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

SWOG Cancer Research Network

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Meghna S Trivedi, SWOG Cancer Research Network

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de mayo de 2019

Finalización primaria (Actual)

8 de abril de 2025

Finalización del estudio (Estimado)

1 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de mayo de 2019

Primero enviado que cumplió con los criterios de control de calidad

3 de mayo de 2019

Publicado por primera vez (Actual)

6 de mayo de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • S1714
  • UG1CA189974 (Subvención/contrato del NIH de EE. UU.)
  • S1714 (Otro identificador: CTEP)
  • NCI-2018-01568 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • SWOG-S1714 (Otro identificador: DCP)
  • S1714 (Otro identificador: SWOG)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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