Status:

COMPLETED

Biomarkers in Chemotherapy-Induced Peripheral Neurotoxicity

Lead Sponsor:

Dartmouth-Hitchcock Medical Center

Collaborating Sponsors:

Disarm Therapeutics

Conditions:

CIPN - Chemotherapy-Induced Peripheral Neuropathy

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This pilot study will attempt to establish the feasibility of using tissue oxygen measurements and the protein, neurofilament light chain (NF-L), as potential biomarkers for chemotherapy-induced perip...

Detailed Description

Therapy with chemotherapeutic drugs can make a huge impact on survival and quality of life in patients with cancer. Advances in medical monitoring and the effectiveness of these therapies have signifi...

Eligibility Criteria

Inclusion

  • Scheduled to receive chemotherapy with taxane compounds for the treatment of breast cancer.
  • No prior taxane or platinum chemotherapy prior to enrollment.
  • Life expectancy greater than or equal to 12 months.
  • Able to provide independent informed consent for the study.
  • Able to undergo EPR oximetry
  • Age 18 years or older

Exclusion

  • Central nervous system or other impairments that interfere with clinical and electrophysiological assessment.
  • Unable to provide independent informed consent.
  • Pacemaker or other metallic objects that would be contraindicated for MRI.
  • A requirement for supplemental oxygen at baseline, or known, severe chronic obstructive pulmonary disease .
  • Previous exposure to neurotoxic chemotherapeutic agents.

Key Trial Info

Start Date :

March 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 14 2022

Estimated Enrollment :

7 Patients enrolled

Trial Details

Trial ID

NCT03348956

Start Date

March 1 2018

End Date

February 14 2022

Last Update

June 20 2024

Active Locations (1)

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Dartmouth-Hitchcock Medical Center in Lebanon, NH

Lebanon, New Hampshire, United States, 03766