Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY) (EPIPHANY)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03997981 |
Recruitment Status :
Recruiting
First Posted : June 25, 2019
Last Update Posted : March 15, 2022
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Condition or disease |
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Chemotherapy-induced Peripheral Neuropathy |
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY) |
Actual Study Start Date : | June 14, 2019 |
Estimated Primary Completion Date : | October 15, 2023 |
Estimated Study Completion Date : | October 15, 2023 |

Group/Cohort |
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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 |
- Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy [ Time Frame: Through study completion, 2 years ]Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997981
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | ClinicalTrials.gov@lilly.com |
United States, Arizona | |
University of Arizona Cancer Center | Not yet recruiting |
Tucson, Arizona, United States, 85724 | |
Principal Investigator: Pavani Chalasani, MD, MPH | |
United States, California | |
Marin Cancer Center | Not yet recruiting |
Greenbrae, California, United States, 94904 | |
Contact 415-925-5000 | |
Principal Investigator: Kristin Anderson, MD | |
United States, Florida | |
Alpha Oncology Research LLC | Recruiting |
Orange City, Florida, United States, 32763 | |
Contact 407-353-1915 | |
Principal Investigator: Santosh Nair, MD | |
United States, Maryland | |
University of Maryland | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Principal Investigator: Susan Dorsey, Ph.D, RN, FAAN | |
Johns Hopkins University School of Medicine | Not yet recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact 410-955-8893 | |
Principal Investigator: N Wagner- Johnston | |
United States, Michigan | |
University of Michigan | Completed |
Ann Arbor, Michigan, United States, 48109 | |
United States, Missouri | |
Washington University | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Principal Investigator: Simon Haroutounian, Ph.D, MSc | |
United States, New York | |
Mayo Clinic | Not yet recruiting |
Rochester, New York, United States, 55905 | |
Principal Investigator: Nathan Staff, MD, Ph.D | |
United States, Ohio | |
OSU- James Comprehensive Cancer Center | Recruiting |
Columbus, Ohio, United States, 43212 | |
Principal Investigator: Maryam Lustberg, MD, MPH | |
United States, Pennsylvania | |
University of Pensylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Principal Investigator: Chafic Karam | |
United States, Vermont | |
University of Vermont Medical Center | Recruiting |
Burlington, Vermont, United States, 05401 | |
Principal Investigator: Noah Kolb, MD | |
United States, Virginia | |
VCU Medical Center | Recruiting |
Richmond, Virginia, United States, 23298-0211 | |
Principal Investigator: Gordon Smith, MD |
Study Director: | 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 |
Responsible Party: | Disarm Therapeutics |
ClinicalTrials.gov Identifier: | NCT03997981 |
Other Study ID Numbers: |
18232 H7I-MC-S028 ( Other Identifier: Eli Lilly and Company ) 10001 ( Other Identifier: Disarm Therapeutics ) |
First Posted: | June 25, 2019 Key Record Dates |
Last Update Posted: | March 15, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
CIPN |
Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |