Influence of low-dose esketamine on postoperative depressive symptoms in patients with breast cancer (EASE): study protocol for a randomised controlled trial
Cen Chen, Qingfeng Wei, Jiajia Zhu, Bin Mei, Xuesheng Liu
BMJ Open September 25, 2023 DOI: 10.1136/bmjopen-2023-075767 via DOAJ
Summary
A planned trial will test whether a low dose of the anesthetic esketamine, given before and during surgery, reduces depressive symptoms in women with breast cancer who are undergoing radical mastectomy. The study will randomly assign 108 women with mild-to-severe depression to receive either esketamine or a saline placebo. The main outcome is the proportion of patients whose depressive symptoms improve by the third day after surgery. The study also will measure changes in a brain protein called brain-derived neurotrophic factor and in resting-state brain connectivity, aiming to uncover how esketamine might work.
Study at a glance
| Characteristics | Randomized controlled trial Placebo-controlled Double-blind Peer reviewed |
|---|---|
| Sample size | 108 |
| Population | Female patients with breast cancer exhibiting mild-to-severe depressive symptoms who are slated for radical mastectomy |
| Citations | 7 |
| Key finding | The trial protocol describes a planned investigation; no results are reported. |
Abstract
Introduction Depressive 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 analysis This 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 dissemination The 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 number Chinese Clinical Trials Registry (ChiCTR2300071062).