Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY) (EPIPHANY)

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-induced Peripheral Neuropathy

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: ClinicalTrials.gov@lilly.com

Study Locations

• United States
  • Florida
    • DeBary, Florida, United States, 32713
      • Completed
      • Alpha Oncology Research LLC
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Not yet recruiting
      • Johns Hopkins University School of Medicine
      • Contact: Phone Number: 410-955-8893
      • Principal Investigator: Nina Wagner- Johnston
    • Baltimore, Maryland, United States, 21201-1544
      • Recruiting
      • University of Maryland School of Medicine
      • Principal Investigator: Susan Dorsey, Ph.D, RN, FAAN
      • Contact: Phone Number: 410-706-7250
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0400
      • Recruiting
      • University of Michigan
      • Principal Investigator: Ellen Smith, PhD, APRN, AOCN, FAAN
      • Contact: Phone Number: 734-936-1267
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0002
      • Completed
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Completed
      • Washington University Medical School
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Completed
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pensylvania Hospital
      • Contact: Phone Number: 215-615-3820
      • Principal Investigator: Chafic Karam
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Recruiting
      • University of Vermont Medical Center
      • Principal Investigator: Noah Kolb, MD
      • Contact: Phone Number: 802-847-4589
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • VCU Medical Center
      • Principal Investigator: Gordon Smith, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll approximately 200 participants from a total of approximately 10 sites in the United States. Each participant will participate for a duration of up to 1 year after the first dose of chemotherapy.

Description

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 curative intent (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 (planned minimum of 12 cycles). May consider Stage IV with minimal metastatic confirmed with Sponsor prior to enrollment
• Bortezomib use in untreated multiple myeloma: Total of 4 months (planned minimum of 9 cycles)
• Written informed consent given
• Enrollment must be completed prior to receiving the first dose of chemotherapy

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 by patient report of frequent numbness or tingling in the hands or feet
• Any uncontrolled serious illness or medical condition that would impact the conduct of the 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 neuromuscular disease) or history of stoke or history of traumatic brain injury
• General anesthesia less than one month prior to the first dose of neurotoxic chemotherapy

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Breast cancer patients with weekly/biweekly paclitaxel regimen
Breast cancer patients receiving docetaxel regimen
Lymphoma patients receiving vincristine regimen
Multiple myeloma patients receiving bortezomib regimen
Colorectal cancer patients receiving oxaliplatin-based regimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy	Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy	Through study completion, 2 years

Collaborators and Investigators

• Sponsor: Disarm Therapeutics
• Collaborators: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): April 9, 2024

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: CIPN
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 18232; 10001 (Disarm Therapeutics); H7I-MC-S028 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No