Endpoints
sleep disturbance, CIPN, pain, NRS pain, Neurotoxicity, Cancer
ONCOLOGY, ADVERSE EVENTS, CANCER
The primary efficacy endpoint was the change in NRS pain score from baseline to week 12 [Secondary efficacy endpoints included changes from baseline to weeks 4 and 12 in NRS scores in the last 7 days for tingling (0 = “no tingling” to 10 = “worst tingling possible”) and sleep disturbance (0 = “no sleep disturbance” to 10 = “sleep completely disturbed by pain”); cases of dose reduction, suspension, and discontinuation of chemotherapy during the study period; sensory CIPN severity as assessed by CTCAE version 5.0 at baseline, week 4, and week 12, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity subscale (FACT/GOG-NTX) [The permissions for the FACT/GOG-NTX and Modified TNSr were obtained in advance as follows. For FACT/GOG-NTX, the FACIT and all related works are owned and copyrighted by and the intellectual property of David Cella, Ph.D; permission for use of the FACT/GOG-NTX is obtained by contacting Dr. Cella at information@facit.org. For the Modified TNSr, all licensed works and derivative works shall be marked as appropriate with the following: “Copyright Johns Hopkins University (2023). All rights reserved.”The safety endpoint was the incidence of adverse events (AEs). AEs were coded using the Japanese version of the Medical Dictionary for Regulatory Activities, version 25.0.