Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer

Sponsor
Southwest Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03939481
Collaborator
National Cancer Institute (NCI) (NIH)
1,336
169
84
7.9
0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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.

  2. 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:
  1. 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.

Study Design

Study Type:
Observational
Actual Enrollment :
1336 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane-Induced Peripheral Neuropathy in Cancer Patients
Actual Study Start Date :
Mar 1, 2019
Anticipated Primary Completion Date :
Feb 28, 2025
Anticipated Study Completion Date :
Feb 28, 2026

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Chemotherapy
Given chemotherapy regimen
Other Names:
  • Chemo
  • Chemotherapy (NOS)
  • Chemotherapy, Cancer, General
  • Other: Functional Assessment
    Functional and sensory clinician assessments

    Other: Questionnaire Administration
    Patient and physician reported responses

    Outcome Measures

    Primary Outcome Measures

    1. Development of peripheral neuropathy [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 as the taxane-based chemotherapy regimens in this study are expected to be completed within 8 to 18 weeks. The presence of CIPN will be captured at 52 weeks to evaluate the duration of neuropathy which is anticipated to wane after treatment discontinuation.

    Secondary Outcome Measures

    1. CIPN symptoms [Up to 52 weeks]

      Patients experiencing a treatment change attributed to CIPN symptoms

    2. Dose Changes [Up to 52 weeks]

      Dose reductions, delays, and discontinuations of treatment (prior to completing the original treatment plan)

    3. Health-related Quality of Life [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.

    4. Visual Analog Toxicity Score [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).

    5. Patient Reported Symptom [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]).

    6. Leisure-time Exercise Habits [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.

    7. Patient-Reported Outcomes [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".

    8. National Cancer Institute-Common Terminology Criteria for Adverse Events [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.

    9. Assess incidence of CIPN [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Permanente-Deer Valley Medical Center Antioch California United States 94531
    2 Kaiser Permanente Dublin Dublin California United States 94568
    3 Kaiser Permanente-Fremont Fremont California United States 94538
    4 Kaiser Permanente-Fresno Fresno California United States 93720
    5 Kaiser Permanente-Oakland Oakland California United States 94611
    6 Desert Regional Medical Center Palm Springs California United States 92262
    7 Kaiser Permanente-San Francisco San Francisco California United States 94115
    8 Kaiser Permanente-Santa Teresa-San Jose San Jose California United States 95119
    9 Kaiser Permanente San Leandro San Leandro California United States 94577
    10 Kaiser San Rafael-Gallinas San Rafael California United States 94903
    11 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051
    12 Kaiser Permanente-Santa Rosa Santa Rosa California United States 95403
    13 Kaiser Permanente Medical Center-Vacaville Vacaville California United States 95688
    14 Kaiser Permanente-Vallejo Vallejo California United States 94589
    15 Kaiser Permanente-Walnut Creek Walnut Creek California United States 94596
    16 Rocky Mountain Regional VA Medical Center Aurora Colorado United States 80045
    17 Bayhealth Hospital Kent Campus Dover Delaware United States 19901
    18 Bayhealth Hospital Sussex Campus Milford Delaware United States 19963
    19 Florida Gynecologic Oncology Fort Myers Florida United States 33905
    20 Regional Cancer Center-Lee Memorial Health System Fort Myers Florida United States 33905
    21 Sacred Heart Hospital Pensacola Florida United States 32504
    22 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    23 Hawaii Cancer Care - Savio 'Aiea Hawaii United States 96701
    24 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    25 Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii United States 96813
    26 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    27 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
    28 Kaiser Permanente Moanalua Medical Center Honolulu Hawaii United States 96819
    29 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    30 Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii United States 96766
    31 Centralia Oncology Clinic Centralia Illinois United States 62801
    32 Carle on Vermilion Danville Illinois United States 61832
    33 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    34 Decatur Memorial Hospital Decatur Illinois United States 62526
    35 Carle Physician Group-Effingham Effingham Illinois United States 62401
    36 Crossroads Cancer Center Effingham Illinois United States 62401
    37 Little Company of Mary Hospital Evergreen Park Illinois United States 60805
    38 Edward Hines Jr VA Hospital Hines Illinois United States 60141
    39 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
    40 Trinity Medical Center Moline Illinois United States 61265
    41 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    42 Carle Cancer Center Urbana Illinois United States 61801
    43 The Carle Foundation Hospital Urbana Illinois United States 61801
    44 McFarland Clinic PC - Ames Ames Iowa United States 50010
    45 Physicians' Clinic of Iowa PC Cedar Rapids Iowa United States 52402
    46 Mercy Hospital Cedar Rapids Iowa United States 52403
    47 Oncology Associates at Mercy Medical Center Cedar Rapids Iowa United States 52403
    48 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    49 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    50 Greater Regional Medical Center Creston Iowa United States 50801
    51 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    52 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    53 Broadlawns Medical Center Des Moines Iowa United States 50314
    54 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    55 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    56 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    57 HaysMed University of Kansas Health System Hays Kansas United States 67601
    58 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    59 Olathe Health Cancer Center Olathe Kansas United States 66061
    60 Salina Regional Health Center Salina Kansas United States 67401
    61 University of Kansas Health System Saint Francis Campus Topeka Kansas United States 66606
    62 Associates In Womens Health Wichita Kansas United States 67208
    63 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    64 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    65 Flaget Memorial Hospital Bardstown Kentucky United States 40004
    66 Saint Joseph Hospital East Lexington Kentucky United States 40509
    67 Saint Joseph London London Kentucky United States 40741
    68 Louisiana State University Health Science Center New Orleans Louisiana United States 70112
    69 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
    70 University Medical Center New Orleans New Orleans Louisiana United States 70112
    71 LSU Health Sciences Center at Shreveport Shreveport Louisiana United States 71103
    72 Harold Alfond Center for Cancer Care Augusta Maine United States 04330
    73 Waldo County General Hospital Belfast Maine United States 04915
    74 MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine United States 04005
    75 Penobscot Bay Medical Center Rockport Maine United States 04856
    76 MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine United States 04073
    77 Maine Medical Center- Scarborough Campus Scarborough Maine United States 04074
    78 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    79 University of Maryland Shore Medical Center at Easton Easton Maryland United States 21601
    80 Lahey Hospital and Medical Center Burlington Massachusetts United States 01805
    81 Winchester Hospital Winchester Massachusetts United States 01890
    82 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    83 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    84 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    85 Munson Medical Center Traverse City Michigan United States 49684
    86 Metro Health Hospital Wyoming Michigan United States 49519
    87 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    88 Minnesota Oncology - Burnsville Burnsville Minnesota United States 55337
    89 Mercy Hospital Coon Rapids Minnesota United States 55433
    90 Essentia Health - Deer River Clinic Deer River Minnesota United States 56636
    91 Essentia Health Cancer Center Duluth Minnesota United States 55805
    92 Fairview Southdale Hospital Edina Minnesota United States 55435
    93 Unity Hospital Fridley Minnesota United States 55432
    94 Essentia Health Hibbing Clinic Hibbing Minnesota United States 55746
    95 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
    96 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    97 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    98 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    99 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    100 Monticello Cancer Center Monticello Minnesota United States 55362
    101 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    102 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    103 Regions Hospital Saint Paul Minnesota United States 55101
    104 United Hospital Saint Paul Minnesota United States 55102
    105 Essentia Health Sandstone Sandstone Minnesota United States 55072
    106 Lakeview Hospital Stillwater Minnesota United States 55082
    107 Essentia Health Virginia Clinic Virginia Minnesota United States 55792
    108 Rice Memorial Hospital Willmar Minnesota United States 56201
    109 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    110 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
    111 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    112 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    113 Mercy Hospital Springfield Springfield Missouri United States 65804
    114 CHI Health Saint Francis Grand Island Nebraska United States 68803
    115 Saint Joseph Hospital Nashua New Hampshire United States 03060
    116 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    117 Randolph Hospital Asheboro North Carolina United States 27203
    118 AdventHealth Infusion Center Asheville Asheville North Carolina United States 28803
    119 Cone Health Cancer Center at Alamance Regional Burlington North Carolina United States 27215
    120 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
    121 AdventHealth Infusion Center Haywood Clyde North Carolina United States 28721
    122 CaroMont Regional Medical Center Gastonia North Carolina United States 28054
    123 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
    124 Cone Health Cancer Center Greensboro North Carolina United States 27403
    125 AdventHealth Hendersonville Hendersonville North Carolina United States 28792
    126 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
    127 CarolinaEast Medical Center New Bern North Carolina United States 28561
    128 FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina United States 28374
    129 Nash General Hospital Rocky Mount North Carolina United States 27804
    130 NHRMC Radiation Oncology - Supply Supply North Carolina United States 28462
    131 New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington North Carolina United States 28401
    132 Trinity Cancer Care Center Minot North Dakota United States 58701
    133 Cleveland Clinic Akron General Akron Ohio United States 44307
    134 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
    135 Kaiser Permanente Northwest Portland Oregon United States 97227
    136 Phoenixville Hospital Phoenixville Pennsylvania United States 19460
    137 Kent Hospital Warwick Rhode Island United States 02886
    138 AnMed Health Cancer Center Anderson South Carolina United States 29621
    139 Saint Joseph's/Candler - Bluffton Campus Bluffton South Carolina United States 29910
    140 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
    141 McLeod Regional Medical Center Florence South Carolina United States 29506
    142 Gibbs Cancer Center-Gaffney Gaffney South Carolina United States 29341
    143 Saint Francis Hospital Greenville South Carolina United States 29601
    144 Prisma Health Cancer Institute - Butternut Greenville South Carolina United States 29605
    145 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    146 Saint Francis Cancer Center Greenville South Carolina United States 29607
    147 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    148 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    149 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
    150 South Carolina Cancer Specialists PC Hilton Head Island South Carolina United States 29926-3827
    151 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    152 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    153 MGC Hematology Oncology-Union Union South Carolina United States 29379
    154 Cookeville Regional Medical Center Cookeville Tennessee United States 38501
    155 Ballad Health Cancer Care - Kingsport Kingsport Tennessee United States 37660
    156 UMC Cancer Center / UMC Health System Lubbock Texas United States 79415
    157 Texas Tech University Health Sciences Center-Lubbock Lubbock Texas United States 79430
    158 Wellmont Medical Associates-Bristol Bristol Virginia United States 24201
    159 University of Virginia Cancer Center Charlottesville Virginia United States 22908
    160 Bon Secours Memorial Regional Medical Center Mechanicsville Virginia United States 23116
    161 Bon Secours Saint Francis Medical Center Midlothian Virginia United States 23114
    162 Bon Secours Saint Mary's Hospital Richmond Virginia United States 23226
    163 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
    164 Jefferson Healthcare Port Townsend Washington United States 98368
    165 Duluth Clinic Ashland Ashland Wisconsin United States 54806
    166 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    167 Instituto Nacional del Cancer Independence Chile 8380455
    168 Instituto Nacional De Cancerologia Bogota Colombia 99999
    169 Instituto Nacional De Cancerologia de Mexico Mexico City Tlalpan Mexico 14080

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Meghna S Trivedi, Southwest Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT03939481
    Other Study ID Numbers:
    • S1714
    • NCI-2018-01568
    • S1714
    • SWOG-S1714
    • S1714
    • UG1CA189974
    First Posted:
    May 6, 2019
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022

    Study Results

    No Results Posted as of May 5, 2022