Influence of low-dose esketamine on postoperative depressive symptoms in patients with breast cancer (EASE): study protocol for a randomised controlled trial

Abstract

IntroductionDepressive symptoms have surfaced as the principal mental health concern among patients with breast cancer, with surgical interventions potentially exacerbating these symptoms and adversely influencing clinical outcomes. This study protocol is designed to investigate the efficacy of low-dose esketamine administered perioperatively on depressive symptoms in patients with breast cancer. It also aims to illuminate the potential neurobiological underpinnings of this effect.Methods and analysisThis research represents a single-centre, prospective, randomised, double-blind, placebo-controlled study. The trial anticipates enrolling 108 female patients exhibiting mild-to-severe depressive symptoms who are slated for radical mastectomy. Through stratified randomisation, eligible patients will be systematically assigned to either the esketamine group (0.25 mg/kg) or placebo group (0.9% saline) in a 1:1 ratio. The primary outcome is the response rate at the third postoperative day. Secondary outcomes encompass the remission rate, depression-related scores, depression severity and safety-related endpoints. Tertiary (exploratory) outcomes involve alterations in brain-derived neurotrophic factor and resting-state functional brain connectivity.Ethics and disseminationThe Clinical Trial Ethics Committee at The First Affiliated Hospital of Anhui Medical University has conferred ethical approvals for this trial (approval number: PJ2023-05-25). Results from this trial will be disseminated in peer-reviewed journals and presented at professional symposiums.Trial registration numberChinese Clinical Trials Registry (ChiCTR2300071062).

Efficacy and safety of low-dose esketamine for painless gastrointestinal endoscopy in adults: a systematic evaluation and meta-analysis

“…Studies have shown that esketamine is associated with a lower rate of adverse reactions than ketamine and demonstrates strong potential to assist anesthesia (Wang et al, 2019). Low-dose esketamine is defined as a dosage of esketamine less than or equal to 0.25 mg/kg (Wei et al, 2023). Previous studies have shown that low-dose esketamine has sympathomimetic effects (Timm et al, 2008).…”

Non-pharmaceutical interventions for depressive symptoms in patients with breast cancer: protocol for a systematic review and network meta-analysis

“… 2 Depressive symptoms have become a significant mental health issue among patients with breast cancer, and have become a crucial concern in both clinical practice and public health. 3 Patients with breast cancer are at a higher risk of developing depressive symptoms following diagnosis and treatment compared with patients with non-breast cancer, and there may be some biological link between major depressive disorder and breast cancer. 4 5 A systematic evaluation and meta-analysis of studies on the prevalence of depression in patients with breast cancer worldwide revealed a global prevalence rate of 32.2%.…”