StudyFinder
Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)
Recruiting
18 years and over
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
drug: Vincristine, drug: Paclitaxel, drug: Oxaliplatin, drug: Docetaxel, drug: Bortezomib
Chemotherapy-induced Peripheral Neuropathy
CIPN
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or - ClinicalTrials.gov@lilly.com
Smith, Albert Gordon
N/A
HM20016182
NCT03997981
See this study on ClinicalTrials.gov