A Study of Chemotherapy-induced Peripheral Neuropathy
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 19-004554
NCT ID: NCT03997981
Sponsor Protocol Number: 10001
About this study
The purpose of this study is to collect clinical and biomarker data from patients receiving neurotoxic chemotherapy who are at risk for developing Chemotherapy-induced Peripheral Neuropathy (CIPN).
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Age ≥ 18 years old.
- Life expectancy ≥ 6 months.
- Patients 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
- Lymphoma only:
- Incident lymphoma initiating treatment with vincristine.
- Planned minimum of four cycles of chemotherapy.
- Oxaliplatin-based regimens, Stage III colorectal cancer: Total of 6 months (12 cycles)
- Bortezomib use in untreated multiple myeloma: Total of 4 months (9 cycles)
- Enrollment must be completed prior to receiving the first dose of neurotoxic chemotherapy.
- 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 (such as Platins, taxane, vinca alkaloids, epothilones, proteasome inhibitors, or immunomodulatory drugs).
- Pre-existing neurodegenerative disease (Parkinson's, Alzheimer's, Huntington's, etc.), neuromuscular disorder (multiple sclerosis, ALS, polio, hereditary neuromuscular disease) or history of stroke or history of traumatic brain injury.
- General anesthesia less than one month prior to enrollment.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Nathan Staff, M.D., Ph.D.
Closed for enrollment
Cancer Center Clinical Trials Referral Office
Publications are currently not available