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Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY) (EPIPHANY)

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 : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Disarm Therapeutics

Study Description
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Brief Summary:
This is a prospective natural history study of CIPN in approximately 200 participants receiving taxanes (paclitaxel, docetaxel) for breast cancer or vincristine for lymphoma. Participants will be enrolled over approximately 1-year. Demographic data, medical history, electronic PROs, ClinROs and NF-L 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. NF-L 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. NF-L 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.

Condition or disease
Chemotherapy-induced Peripheral Neuropathy

Study Design
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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 : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Breast cancer patients with weekly/biweekly paclitaxel regimen
Breast cancer patients receiving docetaxel regimen
Lymphoma patients receiving vincristine regimen


Outcome Measures
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Primary Outcome Measures :
  1. 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 Without DNA
Serum samples collected for measuring Neurofilament light (NF-L) biomarker

Eligibility Criteria
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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
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. Approximately 130 breast cancer participants will be enrolled (approximately 65 participants receiving paclitaxel and 65 receiving docetaxel). Approximately 65 participants with lymphoma receiving vincristine will be enrolled
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
  • 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)

  • Lymphoma only:

    • Incident lymphoma initiating treatment with vincristine
    • Planned minimum of 4 cycles of chemotherapy
  • 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 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
  • General anesthesia less than one month prior to enrollment
  • Current use of other adjuvant pharmacologic interventions (eg, duloxetine, gabapentin, pregabalin, venlafaxine) with known or hypothesized efficacy for treatment or prevention of peripheral neuropathy at study entry.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Ritu Namdev 925-596-4241 rnamdev@disarmtx.com

Locations
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United States, Arizona
University of Arizona Cancer Center Not yet recruiting
Tucson, Arizona, United States, 85724
Principal Investigator: Pavani Chalasani, MD, MPH         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Susan Dorsey, Ph.D, RN, FAAN         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Ellen Smith, PhD, APRN, AOCN, FAAN         
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: Christyn Edmundson, MD         
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         
Sponsors and Collaborators
Disarm Therapeutics
Investigators
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Study Director: Mark Hurtt, M.D. Disarm Therapeutics
More Information
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Responsible Party: Disarm Therapeutics
ClinicalTrials.gov Identifier: NCT03997981    
Other Study ID Numbers: 10001
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Disarm Therapeutics:
CIPN
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases