Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)

Last updated: February 29, 2024
Sponsor: Disarm Therapeutics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT03997981
18232
H7I-MC-S028
10001
  • Ages > 18
  • All Genders

Study Summary

This is a prospective natural history study of CIPN in approximately 200 participants receiving taxanes (paclitaxel, docetaxel) for breast cancer, bortezomib for multiple myeloma, oxaliplatin-based regimens for colorectal cancer, or vincristine for lymphoma.. Demographic data, medical history, electronic PROs, ClinROs blood biomarkers including NF-L, PGx DNA analyses and Bedside-QST will be assessed at Baseline. The Observation Period will initiate with the first dose of chemotherapy and conclude with the last dose of chemotherapy. During the Observation Period, participants will be evaluated for the development of CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will be measured at various timepoints corresponding with treatment regimen schedules throughout the observation period. The Post Chemotherapy Follow-up Period will begin with the first visit after the last dose of chemotherapy and conclude 6 months after the last dose of chemotherapy. During the Post Chemotherapy Follow-up Period, participants will be evaluated for CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will also be measured at the beginning and at the end of the Post-Chemotherapy Follow-up Period. PROs will be assessed electronically on a monthly basis.

Eligibility Criteria

Inclusion

Inclusion Criteria: All of the following criteria must be met in order to be enrolled in the study:

  • Age ≥18 years
  • Life expectancy ≥6 months
  • Participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade 0 CIPN (exception, patients with multiple myeloma treated with bortezomib, CTCAE Grade <=1)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Breast cancer only:
  • Breast cancer beginning treatment with paclitaxel or docetaxel with curativeintent (i.e., not metastatic disease beyond regional lymph nodes)
  • Planned minimum of 6 cycles of chemotherapy
  • Lymphoma only:
  • Incident lymphoma initiating treatment with vincristine
  • Planned minimum of 4 cycles of chemotherapy
  • Oxaliplatin-based regimens, Stage III colorectal cancer: Total of 6 months (plannedminimum of 12 cycles). May consider Stage IV with minimal metastatic confirmed withSponsor prior to enrollment
  • Bortezomib use in untreated multiple myeloma: Total of 4 months (planned minimum of 9cycles)
  • Written informed consent given
  • Enrollment must be completed prior to receiving the first dose of chemotherapy

Exclusion

Exclusion Criteria: Patients meeting ANY of the following criteria are not eligible for participation:

  • Evidence of central nervous system metastases
  • Evidence of clinically significant peripheral neuropathy (CTCAE >2) as defined bypatient report of frequent numbness or tingling in the hands or feet
  • Any uncontrolled serious illness or medical condition that would impact the conduct ofthe current study
  • Previous exposure to neurotoxic chemotherapy drugs
  • Pre-existing neurodegenerative disease (Parkinson's, Alzheimer's, Huntington's, etc.),neuromuscular disorder (multiple sclerosis, ALS, polio, hereditary neuromusculardisease) or history of stoke or history of traumatic brain injury
  • General anesthesia less than one month prior to the first dose of neurotoxicchemotherapy

Study Design

Total Participants: 200
Study Start date:
July 03, 2019
Estimated Completion Date:
April 09, 2024

Connect with a study center

  • University of Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Marin Cancer Center

    Greenbrae, California 94904
    United States

    Site Not Available

  • Alpha Oncology Research LLC

    DeBary, Florida 32713
    United States

    Completed

  • Alpha Oncology Research LLC

    Orange City, Florida 32763
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201-1544
    United States

    Active - Recruiting

  • University of Maryland School of Medicine

    Baltimore, Maryland 21201-1544
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109-0400
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905-0002
    United States

    Completed

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University Medical School

    Saint Louis, Missouri 63110
    United States

    Completed

  • OSU- James Comprehensive Cancer Center

    Columbus, Ohio 43212
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43212
    United States

    Completed

  • University of Pensylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pensylvania Hospital

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Active - Recruiting

  • VCU Medical Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

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