Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)

Disarm Therapeutics

Status

Enrolling

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study type

Observational

Funder types

Industry

Identifiers

NCT03997981

10001

18232

H7I-MC-S028 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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