Clinical trial NCT03997981: Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)
Official title: Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: CIPN
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2019-06-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy
timeFrame: Through study completion, 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: DeBary
country: United States
facility: Alpha Oncology Research LLC
state: Florida
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pensylvania Hospital
state: Pennsylvania
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Richmond
country: United States
facility: VCU Medical Center
state: Virginia
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: