Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

— EPIPHANY  

Official title:

Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03997981
• Other study ID #: 18232
• Secondary ID: H7I-MC-S02810001
• Status: Recruiting
• Start date: July 3, 2019
• Est. completion date: April 9, 2024

Study information

• Verified date: February 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 9, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Ohio State University	Columbus	Ohio
United States	Alpha Oncology Research LLC	DeBary	Florida
United States	University of Pensylvania Hospital	Philadelphia	Pennsylvania
United States	VCU Medical Center	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University Medical School	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Disarm Therapeutics	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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