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Behandlingseffekter på utveckling av kemoterapi-inducerad perifer neuropati hos patienter med cancer

10 september 2026 uppdaterad av: SWOG Cancer Research Network

En prospektiv observationskohortstudie för att utveckla en prediktiv modell av taxaninducerad perifer neuropati hos cancerpatienter

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

1336

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Läkemedel: Chemotherapy

Given chemotherapy regimen

Andra namn:
  • Chemo
  • Kemoterapi (NOS)
  • Kemoterapi, Cancer, Allmänt
Övrig: Functional Assessment

Functional and sensory clinician assessments

Övrig: Questionnaire Administration

Patient and physician reported responses

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Development of Peripheral Neuropathy
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
CIPN Symptoms
Tidsram: Up to 52 weeks

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

SWOG Cancer Research Network

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Meghna S Trivedi, SWOG Cancer Research Network

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

14 maj 2019

Primärt slutförande (Faktisk)

8 april 2025

Avslutad studie (Beräknad)

1 februari 2027

Studieregistreringsdatum

Först inskickad

1 maj 2019

Först inskickad som uppfyllde QC-kriterierna

3 maj 2019

Första postat (Faktisk)

6 maj 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • S1714
  • UG1CA189974 (U.S.S. NIH-anslag/kontrakt)
  • S1714 (Annan identifierare: CTEP)
  • NCI-2018-01568 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • SWOG-S1714 (Annan identifierare: DCP)
  • S1714 (Annan identifierare: SWOG)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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