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

February 29, 2024 updated by: Disarm Therapeutics
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Through study completion, 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Disarm Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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