Treating new-onset cognitive complaints after risk-reducing salpingo-oophorectomy: A randomized controlled crossover trial of lisdexamfetamine

Gynecol Oncol. 2024 Nov:190:62-69. doi: 10.1016/j.ygyno.2024.07.689. Epub 2024 Aug 14.

Abstract

Objective: To determine whether the psychostimulant lisdexamfetamine improves subjective and objective measures of cognitive functioning among women genetically at-risk for cancer who have undergone risk-reducing salpingo-oophorectomy and report new-onset executive functioning difficulties.

Methods: 69 participants were assigned to a randomized controlled crossover trial with 6-week trials of active medication (lisdexamfetamine) and placebo, separated by a minimum 2-week washout in an intent-to-treat framework (clinical trial registration number: NCT03187353). At trial baseline, midpoint, and endpoint, participants completed a self-report measure of executive functioning (Brown Attention Deficit Disorder Scale). At study baseline and trial endpoint, participants completed sustained attention, attention/working memory, and verbal learning/memory cognitive tasks. Side effects were assessed at 2, 3, 4, and 6 weeks for each trial.

Results: From trial baseline to trial endpoint, lisdexamfetamine - relative to placebo - significantly improved total scores on the self-report Brown Attention Deficit Disorder Scale (and scores on four of five subdomains) as well as attention and working memory performance. Significantly more participants endorsed side effects across the lisdexamfetamine trial versus placebo; however, trial completion rates were similar, indicating that lisdexamfetamine was nonetheless well-tolerated.

Conclusions: Lisdexamfetamine improved both subjective and objective measures of attention and working memory and could offer women experiencing cognitive difficulties post-risk-reducing salpingo-oophorectomy an alternative therapeutic option.

Keywords: Cognition; Executive function; Intervention; Stimulant; Surgical menopause.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Central Nervous System Stimulants / administration & dosage
  • Central Nervous System Stimulants / adverse effects
  • Central Nervous System Stimulants / therapeutic use
  • Cross-Over Studies*
  • Double-Blind Method
  • Executive Function / drug effects
  • Female
  • Humans
  • Lisdexamfetamine Dimesylate* / administration & dosage
  • Lisdexamfetamine Dimesylate* / adverse effects
  • Lisdexamfetamine Dimesylate* / therapeutic use
  • Middle Aged
  • Ovarian Neoplasms / psychology
  • Ovarian Neoplasms / surgery
  • Salpingo-oophorectomy* / adverse effects

Substances

  • Lisdexamfetamine Dimesylate
  • Central Nervous System Stimulants