E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy
Status:
Withdrawn
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
This project seeks to address cognitive disturbance, which is a frequent adverse sequelae of
riskreducing bilateral salpingo-oophorectomy (RRSO) with or without post-procedure
chemotherapy and adjunctive treatments. RRSO after completion of childbearing is recommended
for prevention of ovarian and breast cancer in women with BRCA1/BRCA2 mutations and standard
of care for women with some forms of hormone-responsive cancer. Knowledge regarding the
impact of this procedure, with or without chemotherapy, and subsequent hypogonadism on brain
health is less than adequate. Premenopausal women who undergo an acute surgical menopause are
at greater risk for verbal memory decline and executive function (EF) complaints, but as of
yet, we cannot predict who is going to experience these adverse sequelae, nor do we have
targeted prevention or treatment strategies other than hormone therapy, which is not an
option in many cases and not always effective. An idealized sample as women who are planning
for a RRSO will undergo brain imaging and behavioral assessments pre- and post-surgery as
well as pre-/post-treatment with E2 or the psychostimulant, lisdexamphetamine (LDX;
Vyvanse®).