Identification of Chemotherapy-Induced Peripheral Neuropathy—A Self-Administered Scoring System Tested in Breast Cancer Survivors: Protocol of the NEURO-BREAC Trial

Background/Objectives: Many patients with breast cancer are treated with chemotherapy, including taxanes. These regimens bear a significant risk of potentially burdensome peripheral neuropathy. A scoring system supported by a neuropathy tracker, which can be self-administered by the patients, likely facilitates and speeds up the diagnosis of chemotherapy-induced peripheral neuropathy (CIPN). Before such a scoring system can be used, determination of the optimal cut-off score to discriminate between CIPN and no CIPN is necessary. The prospective NEURO-BREAC trial (NCT07148336) aims to identify the optimal cut-off score in patients treated with chemotherapy and adjuvant irradiation for breast cancer. Methods: The main goal of the NEURO-BREAC trial is to provide the optimal cut-off of a scoring system to discriminate between moderate to severe CIPN and no CIPN in breast cancer survivors previously treated with paclitaxel- or docetaxel-based chemotherapy and irradiation. The scores (0 to 44 points) are obtained by using a neuropathy tracker. This tracker is based on self-evaluation of symptoms and signs of CIPN by study participants. In addition, satisfaction of the patients with the scoring system is assessed. Twenty-four patients (sixteen patients with moderate to severe CIPN and eight patients without CIPN) are required for the Full Analysis Set. Assuming that about 5% of patients will not qualify for this set, 26 patients should be recruited for the NEURO-BREAC trial. The results of this trial are considered an important step for the development of a scoring system contributing to the identification of CIPN in breast cancer patients.