Observing the effects of chemotherapy on nerve health in cancer patients
Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)
This study is tracking how chemotherapy affects nerve health in cancer patients to see how common nerve problems are during and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (DeBary, Florida and 9 other locations) |
| Trial ID | NCT03997981 on ClinicalTrials.gov |
What this trial studies
This observational study aims to track the natural history of chemotherapy-induced peripheral neuropathy (CIPN) in about 200 participants undergoing treatment for various cancers. Participants will be monitored from the start of chemotherapy through to six months after treatment, with assessments including demographic data, medical history, patient-reported outcomes, clinical assessments, blood biomarkers, and sensory testing. The study focuses on patients receiving specific chemotherapy agents such as taxanes, bortezomib, oxaliplatin, and vincristine, evaluating the development and progression of CIPN throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are starting chemotherapy for breast cancer, lymphoma, colorectal cancer, or multiple myeloma with specific eligibility criteria.
Not a fit: Patients with advanced metastatic disease or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of CIPN, leading to better management strategies for patients undergoing chemotherapy.
How similar studies have performed: While there have been studies on CIPN, this specific observational approach focusing on a diverse range of chemotherapy agents is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
DeBary, Florida and 9 other locations
- Alpha Oncology Research LLC — DeBary, Florida, United States (Completed)
- University of Maryland School of Medicine — Baltimore, Maryland, United States (Recruiting)
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Not_yet_recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Completed)
- Washington University Medical School — Saint Louis, Missouri, United States (Completed)
- Ohio State University — Columbus, Ohio, United States (Completed)
- University of Pensylvania Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Vermont Medical Center — Burlington, Vermont, United States (Recruiting)
- VCU Medical Center — Richmond, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: ClinicalTrials.gov@lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.