Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)

Recruiting

• Conditions: Chemotherapy-induced Peripheral Neuropathy

• Registration Number: NCT03997981
• Lead Sponsor: Disarm Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Study Start: 2019-07-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-04-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (10)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States

University of Pensylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Alpha Oncology Research LLC; 🇺🇸 DeBary, Florida, United States

Washington University Medical School; 🇺🇸 Saint Louis, Missouri, United States

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

VCU Medical Center; 🇺🇸 Richmond, Virginia, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States