Phase
Condition
Neurologic Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 curativeintent (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 (plannedminimum of 12 cycles). May consider Stage IV with minimal metastatic confirmed withSponsor prior to enrollment
- Bortezomib use in untreated multiple myeloma: Total of 4 months (planned minimum of 9cycles)
- Written informed consent given
- Enrollment must be completed prior to receiving the first dose of chemotherapy
Exclusion
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 bypatient report of frequent numbness or tingling in the hands or feet
- Any uncontrolled serious illness or medical condition that would impact the conduct ofthe 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 neuromusculardisease) or history of stoke or history of traumatic brain injury
- General anesthesia less than one month prior to the first dose of neurotoxicchemotherapy
Study Design
Connect with a study center
University of Arizona Cancer Center
Tucson, Arizona 85724
United StatesSite Not Available
Marin Cancer Center
Greenbrae, California 94904
United StatesSite Not Available
Alpha Oncology Research LLC
DeBary, Florida 32713
United StatesCompleted
Alpha Oncology Research LLC
Orange City, Florida 32763
United StatesSite Not Available
Johns Hopkins University School of Medicine
Baltimore, Maryland 21287
United StatesSite Not Available
University of Maryland
Baltimore, Maryland 21201-1544
United StatesActive - Recruiting
University of Maryland School of Medicine
Baltimore, Maryland 21201-1544
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109-0400
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905-0002
United StatesCompleted
Washington University
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Washington University Medical School
Saint Louis, Missouri 63110
United StatesCompleted
OSU- James Comprehensive Cancer Center
Columbus, Ohio 43212
United StatesActive - Recruiting
Ohio State University
Columbus, Ohio 43212
United StatesCompleted
University of Pensylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
University of Pensylvania Hospital
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
University of Vermont Medical Center
Burlington, Vermont 05401
United StatesActive - Recruiting
VCU Medical Center
Richmond, Virginia 23298
United StatesActive - Recruiting
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