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ClinicalTrials.gov
This study is currently recruiting participants.
Verified November 2013 by University of Pennsylvania
Sponsor:
University of Pennsylvania
Information provided by (Responsible Party):
C. Neill Epperson, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01986764
First received: October 30, 2013
Last updated: November 11, 2013
Last verified: November 2013
Purpose
This
project seeks to address cognitive disturbance, which is a frequent
adverse sequelae of risk reducing 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®).
Condition | Intervention |
---|---|
Planned RRSO |
Drug: LDX Drug: Estradiol Drug: Placebo |
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