Chemotherapy-induced Peripheral NeuropathyEPIPHANYNCT03997981
Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Disarm Therapeutics at 10 sites in United States.
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.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- How many people
- 200 participants
- Where
- 10 sitesUnited States
- Study dates
- 3 Jul 2019to 9 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or contact
10 sites in 1 country
United States10 sites, 6 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109-0400
734-936-1267
Ellen Smith, PhD, APRN, AOCN, FAAN
- Recruiting
University of Maryland School of Medicine
Baltimore, Maryland, 21201-1544
410-706-7250
Susan Dorsey, Ph.D, RN, FAAN
- Not yet recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
410-955-8893
Nina Wagner- Johnston
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
802-847-4589
Noah Kolb, MD
- Completed
Ohio State University
Columbus, Ohio, 43212
- Completed
Alpha Oncology Research LLC
DeBary, Florida, 32713
- Recruiting
University of Pensylvania Hospital
Philadelphia, Pennsylvania, 19104
215-615-3820
Chafic Karam
- Recruiting
VCU Medical Center
Richmond, Virginia, 23298
Gordon Smith, MD
- Completed
Mayo Clinic
Rochester, Minnesota, 55905-0002
- Completed
Washington University Medical School
St Louis, Missouri, 63110
About this study
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.
- Keywords
- CIPN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients with weekly/biweekly paclitaxel regimen | Not described | |
| Breast cancer patients receiving docetaxel regimen | Not described | |
| Lymphoma patients receiving vincristine regimen | Not described | |
| Multiple myeloma patients receiving bortezomib regimen | Not described | |
| Colorectal cancer patients receiving oxaliplatin-based regimens | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start3 Jul 2019
- Primary completion31 Mar 2024 (estimated)
- Study completion9 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Disarm Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997981
- Sponsor's protocol ID
- 18232
- Other IDs
- H7I-MC-S028, 10001
- Acronym
- EPIPHANY
- Status last verified
- Feb 2024
- First submitted
- 12 Jun 2019
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)
- ClinicalTrials.gov ID
- NCT03997981
- Acronym / sponsor ID
- EPIPHANY / 18232
- Keywords
- CIPN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Disarm TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 9 Apr 2024 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or contact
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) study director
Eli Lilly and Company
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Disarm Therapeutics at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
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), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.