Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)

NCT03997981 | Recruiting

• 3 other identifiers: 18232H7I-MC-S02810001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

CIPN

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Disarm Therapeutics: lead
• Eli Lilly and Company: collaborator

Study Sites (10)

Alpha Oncology Research LLC

DeBary, Florida, 32713, United States

COMPLETED

University of Maryland School of Medicine

Baltimore, Maryland, 21201-1544, United States

RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109-0400, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905-0002, United States

COMPLETED

Washington University Medical School

St Louis, Missouri, 63110, United States

COMPLETED

Ohio State University

Columbus, Ohio, 43212, United States

COMPLETED

University of Pensylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

VCU Medical Center

Richmond, Virginia, 23298, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples collected for measuring biomarkers

Study Officials

• 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 DIRECTOR

Central Study Contacts

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; ClinicalTrials.gov@lilly.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 25, 2019
• Study Start: July 3, 2019
• Primary Completion: March 31, 2024
• Study Completion: April 9, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)