Protocol for the NEURO-BREAC-02 Trial: Evaluation of a Self-Assessment Tool for Mild Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Survivors.

Background/Objectives: Patients with breast cancer undergoing chemotherapy with taxanes or platin derivates often develop peripheral neuropathy (CIPN). Higher-grade CIPN generally affects the patient's quality of life. Because the treatment options for CIPN are limited, early diagnosis is desirable to allow for timely modifications of the treatment. This may be facilitated with scoring tools that are ideally usable by the patients. A prospective study suggested that a recently developed self-assessment tool might be able to reveal the difference between the absence of CIPN and higher-grade CIPN. When CIPN has reached an advanced grade, alteration of the chemotherapy regimen may have only a limited effect. Therefore, it is important to know whether the new scoring tool can identify CIPN even when it is still mild. The current trial (NCT07604441) aims to identify the optimal cutoff point value for detecting mild CIPN. Given the limited sample size, the derived cutoff will be considered preliminary and will require validation in a larger independent cohort. Methods: The NEURO-BREAC-02 trial aims to identify the optimal cutoff point value of the new tool to distinguish between absent and mild CIPN after treatment with taxanes for breast cancer. Scores ranging between 0 and 44 points are reported via self-assessment supported by a neuropathy tracker. Secondly, the satisfaction of participants with the self-assessment tool is evaluated. Twenty-six participants (19 with mild CIPN and 7 without CIPN) are required, and 28 must be enrolled. Conclusions: The outcomes of the NEURO-BREAC-02 trial are considered crucial for the creation of a self-assessment tool to identify mild CIPN in patients with breast cancer and are a necessary addition to the preceding NEURO-BREAC study.