Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)

Description

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

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Study Overview

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Study Details

Study overview

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.

Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)

Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)

Condition
Chemotherapy-induced Peripheral Neuropathy
Intervention / Treatment

-

Contacts and Locations

DeBary

Alpha Oncology Research LLC, DeBary, Florida, United States, 32713

Baltimore

University of Maryland School of Medicine, Baltimore, Maryland, United States, 21201-1544

Baltimore

Johns Hopkins University School of Medicine, Baltimore, Maryland, United States, 21287

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109-0400

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905-0002

Saint Louis

Washington University Medical School, Saint Louis, Missouri, United States, 63110

Columbus

Ohio State University, Columbus, Ohio, United States, 43212

Philadelphia

University of Pensylvania Hospital, Philadelphia, Pennsylvania, United States, 19104

Burlington

University of Vermont Medical Center, Burlington, Vermont, United States, 05401

Richmond

VCU Medical Center, Richmond, Virginia, United States, 23298

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Disarm Therapeutics,

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2024-04-09