Objectives {7}
non-metastatic breast, Orthostatic fall, neuropathy
LUNG CANCERS, SECONDARY, PERIPHERAL NEUROPATHY, NEUROPATHY
The general aim of this study is to determine the efficacy of oral gabapentin in reducing paclitaxel-induced peripheral neuropathy. We hypothesize that administration of oral gabapentin will decrease the incidence of clinically significant paclitaxel-induced neuropathy (NCI CTCAEv5.0 grade 2 or higher) by 20%, compared to the placebo arm, assuming that 30% of patients in the placebo arm will develop grade 2 or worse peripheral neuropathy [The primary objective of this study is:To compare the effect of oral gabapentin with placebo in preventing clinically significant peripheral neuropathy (incidence of NCI CTCAEv5.0 grade 2 or higher peripheral neuropathy) in patients with non-metastatic breast, gynecological and lung cancers receiving (neo)adjuvant paclitaxelThe secondary objectives are to compare the effect of oral gabapentin with placebo on:Preventing all grades of peripheral neuropathy (incidence of NCI CTCv5.0 any grade peripheral neuropathy)Nerve conduction velocity changes between baseline, 3 months after therapy initiation, and 3 months post-therapy in the following nervesMedian nerveUlnar nerveSural nerveTime to develop clinically detectable neuropathy (from the start of paclitaxel)Patient-reported outcomes (PROs) (EORTC QLQ-CIPN20)Adherence with therapy (Remaining pills in plastic containers)Paclitaxel dose modification (number of patients with dose modifications due to peripheral neuropathy)The safety profile of gabapentin for this indication (NCI CTC version 5)Screening tests for autonomic nervous system function (Orthostatic fall in systolic blood pressure and heart rate variation with deep breathing)