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

  • STATUS
    Recruiting
  • End date
    Oct 15, 2023
  • participants needed
    200
  • sponsor
    Disarm Therapeutics
Updated on 16 March 2022
paclitaxel
cancer
lymphoma
vincristine
metastatic disease
breast cancer
treatment regimen
docetaxel
taxane
peripheral neuropathy
nf-l

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.

Details
Condition Chemotherapy-induced Peripheral Neuropathy
Clinical Study IdentifierNCT03997981
SponsorDisarm Therapeutics
Last Modified on16 March 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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