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Behandelingseffecten op de ontwikkeling van door chemotherapie geïnduceerde perifere neuropathie bij patiënten met kanker

10 september 2026 bijgewerkt door: SWOG Cancer Research Network

Een prospectieve observationele cohortstudie om een ​​voorspellend model te ontwikkelen van taxaan-geïnduceerde perifere neuropathie bij kankerpatiënten

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

1336

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Geneesmiddel: Chemotherapy

Given chemotherapy regimen

Andere namen:
  • Chemo
  • Chemotherapie (NOS)
  • Chemotherapie, kanker, algemeen
Ander: Functional Assessment

Functional and sensory clinician assessments

Ander: Questionnaire Administration

Patient and physician reported responses

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Development of Peripheral Neuropathy
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
CIPN Symptoms
Tijdsspanne: Up to 52 weeks

Patients experiencing a treatment change attributed to CIPN symptoms
Up to 52 weeks
Dose Changes
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

SWOG Cancer Research Network

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Meghna S Trivedi, SWOG Cancer Research Network

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 mei 2019

Primaire voltooiing (Werkelijk)

8 april 2025

Studie voltooiing (Geschat)

1 februari 2027

Studieregistratiedata

Eerst ingediend

1 mei 2019

Eerst ingediend dat voldeed aan de QC-criteria

3 mei 2019

Eerst geplaatst (Werkelijk)

6 mei 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

10 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • S1714
  • UG1CA189974 (Subsidie/contract van de Amerikaanse NIH)
  • S1714 (Andere identificatie: CTEP)
  • NCI-2018-01568 (Register-ID: CTRP (Clinical Trial Reporting Program))
  • SWOG-S1714 (Andere identificatie: DCP)
  • S1714 (Andere identificatie: SWOG)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren