A Study Of Chemotherapy-induced Peripheral Neuropathy

Overview

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).

 

Participation eligibility

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.

Inclusion Criteria:

  •  Age ≥ 18 years old.
  • 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:

  • 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 stroke.
  • General anesthesia less than one month prior to enrollment.
  • Current use of other adjuvant pharmacologic interventions (e.g., duloxetine, gabapentin, pregabalin, venlafaxine) with known or hypothesized effectiveness for treatment or prevention of peripheral neuropathy at study entry.

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 Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Nathan Staff, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Nathan Staff, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20467375

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