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Behandlingseffekter på udvikling af kemoterapi-induceret perifer neuropati hos patienter med kræft

10. september 2026 opdateret af: SWOG Cancer Research Network

En prospektiv observationel kohorteundersøgelse til udvikling af en prædiktiv model for taxaninduceret perifer neuropati hos kræftpatienter

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1336

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: COHORT
Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte Gruppe / kohorte En gruppe eller undergruppe af deltagere i et observationsstudie, der vurderes for biomedicinske eller sundhedsmæssige resultater.	Intervention / Behandling Intervention / Behandling En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
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.	Medicin: Chemotherapy Given chemotherapy regimen Andre navne: Chemo Kemoterapi (NOS) Kemoterapi, Kræft, Generelt Andet: Functional Assessment Functional and sensory clinician assessments Andet: Questionnaire Administration Patient and physician reported responses

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Number of Participants With Development of Peripheral Neuropathy Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
CIPN Symptoms Tidsramme: Up to 52 weeks	Patients experiencing a treatment change attributed to CIPN symptoms	Up to 52 weeks
Dose Changes Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

SWOG Cancer Research Network

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

Ledende efterforsker: Meghna S Trivedi, SWOG Cancer Research Network

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. maj 2019

Primær færdiggørelse (Faktiske)

8. april 2025

Studieafslutning (Anslået)

1. februar 2027

Datoer for studieregistrering

Først indsendt

1. maj 2019

Først indsendt, der opfyldte QC-kriterier

3. maj 2019

Først opslået (Faktiske)

6. maj 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

S1714
UG1CA189974 (U.S. NIH-bevilling/kontrakt)
S1714 (Anden identifikator: CTEP)
NCI-2018-01568 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
SWOG-S1714 (Anden identifikator: DCP)
S1714 (Anden identifikator: SWOG)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Behandlingseffekter på udvikling af kemoterapi-induceret perifer neuropati hos patienter med kræft

En prospektiv observationel kohorteundersøgelse til udvikling af en prædiktiv model for taxaninduceret perifer neuropati hos kræftpatienter

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Prøveudtagningsmetode

Studiebefolkning

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Faktiske)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre